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Roxee Meds Catalog

Sulfadimethoxine

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Solution Multiple FDA labelers Official label facts Owner quick guide first

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Storefront facts
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Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
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  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

Updated: February 12, 2026, 10:44 PM UTC

Sources:
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Sulfadimethoxine

Sulfadimethoxine

Drug type: Generic ingredient • Branded profile FDA branded products available

Both Solution Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Sulfadimethoxine

Treatment of sulfadimethoxine-susceptible bacterial infections. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats. Species commonly shown: Both, Beef, Beef calves.

Generic name
Sulfadimethoxine
Brand names
DI-METHOX®, Albon® Tablets, Di-Methox Injection 40%, Sulfadimethoxine Concentrated Solution 12.5%
Manufacturer
Multiple FDA labelers
Species
Both, Beef, Beef calves, Dairy calves
Dosage forms
Solution, Soluble Powder, Tablet, Liquid (Solution)
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
DI-METHOX® Albon® Tablets Di-Methox Injection 40% Sulfadimethoxine Concentrated Solution 12.5% Sulfadimethoxine Injection 40% Sulfadimethoxine 12.5% Oral Solution Sulfasol Soluble Powder Sulforal® Sulfadimethoxine Soluble Powder Sulfamed-G® SulfaMed® Bactrovet Oral Suspension 12.5% Medacide-SDM Injection 10% Bactrovet Tablets 250 mg Bactrovet Injectable Albon® Albon Oral Suspension 5% ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5% Albon® or Agribon® Albon® S.R. (Sustained Release) SulfaMed Albon Bolus Sulforal SULFADIMETHOXINE 40% Sulfadimethoxine Albon SULFASOL DI-METHOX
Dosage forms
Solution Soluble Powder Tablet Liquid (Solution) Liquid Injection Liquid (Suspension) Bolus Sustained Release Bolus

Indications / Uses

Treatment of sulfadimethoxine-susceptible bacterial infections. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Warnings / Contraindications

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

  • Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Side Effects

Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Lack of efficacy (protozoa) - Coccidia, Death, Facial swelling (see also 'Skin').

FAQ

Both, Beef, Beef calves, Dairy calves, Dairy heifers, Meat type, up to 24 weeks age, Broilers, Replacements, Under 16 weeks, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied, No Use Class Stated Or Implied, Growing, Replacements up to 16 weeks age, Broilers up to 16 weeks, Beef And Dairy, Horse, Not For Meat Production, Dairy, non-lactating

Yes. Roxee shows this as prescription-only.

Solution, Soluble Powder, Tablet, Liquid (Solution)

Source Transparency

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Pet Owner Quick Guide

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Used for:

Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian
  • Do not administer to chickens over 16 weeks of age
  • As sole source of drinking water and sulfonamide medication
  • Withdraw 5 days before slaughter
  • Hives (1 reports)
  • General pain (1 reports)
  • Gastric ulcer (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Major cautions & emergency warning signs

Side effects to monitor:

  • Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian
  • Do not administer to chickens over 16 weeks of age
  • As sole source of drinking water and sulfonamide medication
  • Withdraw 5 days before slaughter
  • Hives

Most reported reactions:

  • Hives (1 reports)
  • General pain (1 reports)
  • Gastric ulcer (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Bolus, Injection, Liquid, Liquid (Solution), Liquid (Suspension), Soluble Powder
Identifiers:
ANADA: 200030 ANADA: 200031 ANADA: 200038 ANADA: 200165 ANADA: 200177 ANADA: 200192 ANADA: 200238 ANADA: 200251 ANADA: 200258 ANADA: 200376 ANADA: 200443 ANADA: 200523 NADA: 100929 NADA: 12087 NADA: 12554 NADA: 125933 NADA: 15102 NADA: 31205 NADA: 31715 NADA: 37700
Source metadata:

Warnings / Contraindications

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

  • High: Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
19
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Drooling, Diarrhea Skin & allergy (2) · Hives, Chewing - pruritus Neurologic (1) · Unsteady walking (ataxia) Behavior (1) · Behavioral disorder (unspecified) Other (24) · Inappetence, Hypoproteinaemia, Hyperthermia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Skin & allergy 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Digestive 1 Cat 1

Species coverage: Dog (26) Cat (6)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Non-serious - 1
Neurologic Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Digestive Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Digestive Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Skin & allergy Dog Serious - 1
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Source metadata:

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

37

FOI

16

Sulfasol Soluble Powder

SPL · SPL

FDA Structured Product Label

Sulfasol Soluble Powder

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra Veterinary Products LLC
ANADA
200-238
Status
RX
Form
Soluble Powder
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine.

Chickens (broilers and replacements)

Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon. The powder is used to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)

Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon. The powder is used to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. The powder is used to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulforal®

SPL · SPL

FDA Structured Product Label

Sulforal®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra Veterinary Products LLC
ANADA
200-251
Status
RX
Form
Liquid (Solution)
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12 percent (3.75 gram per ounce) sulfadimethoxine.

Chickens (broilers and replacements)

Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)

Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication
The oral solution is administered as a cattle drench or diluted as directed to prepare drinking water for treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Di-Methox Injection 40%

SPL · SPL

FDA Structured Product Label

Di-Methox Injection 40%

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-038
Status
RX
Form
Liquid (Solution)
Route
Intravenous
Species
No Use Class Stated Or Implied
Composition / specifications
Each mL contains 400 mg sulfadimethoxine

Cattle

Indication

For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus), sensitive to sulfadimethoxine.

Dosage

To be administered in amounts to provide 25 mg/lb (55 mg/kg) for the initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours. Must be administered only by the intravenous route in cattle. Length of treatment depends on the clinical response. In most cases treatment for 3-5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

Albon Oral Suspension 5%

SPL · SPL

FDA Structured Product Label

Albon Oral Suspension 5%

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
43785
Status
RX
Form
Liquid (Suspension)
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of the drug contains 50 milligrams of sulfadimethoxine.

Cats

Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dogs

Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs.

Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Albon® Tablets

SPL · SPL

FDA Structured Product Label

Albon® Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
15102
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
No specifications are included in the CFR for this product.

Dogs

Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs.






Dosage

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Dosage

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

SulfaMed®

SPL · SPL

FDA Structured Product Label

SulfaMed®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Limited
ANADA
200-523
Status
RX
Form
Injection
Route
Intravenous
Species
No Use Class Stated Or Implied
Composition / specifications
400 mg/mL

Label highlights

Indication
For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine
Dosage
Intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.

Albon®

SPL · SPL

FDA Structured Product Label

Albon®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
41245
Status
RX
Form
Liquid
Route
Intravenous, Subcutaneous
Species
Dog, No Use Class Stated Or Implied • Horse, Not For Meat Production • No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine injection containing 400 milligrams per milliliter.

Horses

Indication
For the treatment of respiratory disease caused by Streptococcus equi (strangles).
Dosage
It is administered by intravenous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours until the patient is asymptomatic for 48 hours.
Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dogs

Indication
For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the treatment of canine bacterial enteritis associated with coccidiosis and canine Salmonellosis.
Dosage
It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.
Limitations
Federal law restricts this drug to use by or on the order of a veterinarian.

Cats

Indication
For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine.
Dosage
It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.
Limitations
Federal law restricts this drug to use by or on the order of a veterinarian.

Cattle

Indication
For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.
Dosage
It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations
Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. Tissue damage may result from perivascular infiltration. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Albon® or Agribon®

SPL · SPL

FDA Structured Product Label

Albon® or Agribon®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
31715
Status
RX
Form
Bolus
Route
Oral
Species
No Use Class Stated Or Implied

Cattle

Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

Dosage
1.25 to 2.5 grams per 100 pounds body weight. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day.

DI-METHOX®

SPL · SPL

FDA Structured Product Label

DI-METHOX®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-031
Status
RX
Form
Soluble Powder
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
107 g (3.77 oz.) pouch: each packet contains 3.34 oz. (94.6 g) of sulfadimethoxine in the form of the soluble salt and disodium edetate. 535 g (18.87 oz.) pouch: each packet contains 16.8 oz. (473 g) of sulfadimethoxine in the form of the soluble salt and disodium edetate.

Chickens (broilers and replacements)

Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 (0.05 percent) grams of powder per gallon of water in drinking water or as a drench. Administer for 6 consecutive days.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)

Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks (168 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.025 percent) as regular drinking water. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. The oral solution is administered as a drench or diluted as directed to prepare drinking water.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Concentrated Solution 12.5%

SPL · SPL

FDA Structured Product Label

Sulfadimethoxine Concentrated Solution 12.5%

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Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-165
Status
RX
Form
Liquid (Solution)
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12 percent (3.75 gram per ounce) sulfadimethoxine.

Chickens (broiler and replacements)

Indication

For treatment of outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams/gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (growing)

Indication

For growing turkeys: For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams/gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age.Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams/gallon (0.031-0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfamed-G®

SPL · SPL

FDA Structured Product Label

Sulfamed-G®

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Sponsor
Bimeda Animal Health Limited
ANADA
200-376
Status
RX
Form
Soluble Powder
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Replacements up to 16 weeks age • Broilers up to 16 weeks
Composition / specifications
107 g (3.77 oz) pouch: each packet contains 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate. 535 g (18.87 oz) pouch: each packet contains 16.8 oz (473 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate. 25 lb (11.34 kg) pail: 3 scoops contain 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.

Chickens (broilers and replacements)

Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)

Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams of powder per gallon to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef cattle)

Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. Federal law prohibits the extralabel use of this product in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

DI-METHOX®

SPL · SPL

FDA Structured Product Label

DI-METHOX®

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Sponsor
Huvepharma EOOD
ANADA
200-030
Status
RX
Form
Solution
Route
Oral
Species
Beef • Beef calves • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12.5 percent (3.75 gram per ounce) sulfadimethoxine.

Chickens (broilers and replacements)

Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)

Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks (168 days) of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.025 percent) as regular drinking water. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

The oral solution is administered as a drench or diluted as directed to prepare drinking water. Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams per gallon of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Medacide-SDM Injection 10%

SPL · SPL

FDA Structured Product Label

Medacide-SDM Injection 10%

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Sponsor
Cronus Pharma Specialities India Private Ltd.
NADA
98569
Status
RX
Form
Liquid
Route
Subcutaneous, Intramuscular, Intravenous
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine containing 100 milligrams per milliliter.

Dogs

Indication
It is used or intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs.
Dosage
It is administered by subcutaneous, intramuscular or intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours thereafter. Continue treatment until the animal is free from symptoms for 48 hours.
Limitations
For use by or on the order of a licensed veterinarian.

Sulfadimethoxine 12.5% Oral Solution

SPL · SPL

FDA Structured Product Label

Sulfadimethoxine 12.5% Oral Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-192
Status
RX
Form
Liquid (Solution)
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Growing • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each ounce of solution contains (3.75 grams (12.5 percent) sulfadimethoxine.

Turkeys (growing)

Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication.Withdraw 5 days before slaughter.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Chickens (broilers and replacements)

Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) ofdrinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. 

Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Injection 40%

SPL · SPL

FDA Structured Product Label

Sulfadimethoxine Injection 40%

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Sponsor
Huvepharma EOOD
ANADA
200-177
Status
RX
Form
Liquid
Route
Intravenous
Species
No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine injection containing 400 milligrams per milliliter

Cattle

Indication
For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.
Dosage
It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations
Tissue damage may result from perivascular infiltration. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Albon®

SPL · SPL

FDA Structured Product Label

Albon®

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Sponsor
Zoetis Inc.
NADA
46285
Status
RX
Form
Soluble Powder
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine (as the sodium salt).

Chickens (broilers and replacements)

Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Turkeys (meat)

Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Cattle (dairy calves, dairy heifers, and beef cattle)

Indication

Treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

ALBON® Concentrated Solution 12.5%

SPL · SPL

FDA Structured Product Label

ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5%

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Sponsor
Zoetis Inc.
NADA
31205
Status
RX
Form
Solution
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each ounce of solution contains (3.75 grams (12.5 percent) sulfadimethoxine.

Chickens (broilers and replacements)

Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Turkeys (growing)

Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Cattle (dairy calves, dairy heifers, and beef)

Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

AGRIBON® Concentrated Solution 12.5%

SPL · SPL

FDA Structured Product Label

ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5%

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
31205
Status
RX
Form
Solution
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each ounce of solution contains (3.75 grams (12.5 percent) sulfadimethoxine.

Chickens (broilers and replacements)

Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Turkeys (growing)

Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Cattle (dairy calves, dairy heifers, and beef)

Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Sulfadimethoxine Soluble Powder

SPL · SPL

FDA Structured Product Label

Sulfadimethoxine Soluble Powder

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Sponsor
Phibro Animal Health Corp.
ANADA
200-258
Status
RX
Form
Liquid (Solution)
Route
Oral
Species
Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine.

Chickens (broilers and replacements)

Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Administer as sole source of drinking water and sulfonamide medication. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)

Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Administer as sole source of drinking water and sulfonamide medication. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

 Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Albon® S.R. (Sustained Release)

SPL · SPL

FDA Structured Product Label

Albon® S.R. (Sustained Release)

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Sponsor
Zoetis Inc.
NADA
93107
Status
RX
Form
Sustained Release Bolus
Route
Oral
Species
Beef • Dairy, non-lactating
Composition / specifications
12.5-gram-sustained-release bolus.

Cattle (beef and nonlactating dairy)

Indication
Treatment of shipping fever complex and bacterial pneumonia associated with organisms such as Pasteurella species sensitive to sulfadimethoxine; calf diphtheria and foot rot associated with Sphaerophorus necrophorus.
Dosage
Administer one bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight.
Limitations
Do not repeat treatment for 7 days. Do not use in lactating dairy cattle. Do not administer within 12 days of slaughter. During treatment make certain that animals maintain adequate water intake. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Bactrovet Injectable

SPL · SPL

This source does not expose a safe inline preview. Use the original source link for the full document.

Bactrovet Oral Suspension 12.5%

SPL · SPL

FDA Structured Product Label

Bactrovet Oral Suspension 12.5%

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Sponsor
Intervet, Inc.
NADA
37700
Status
RX
Form
Liquid
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of the drug contains 50 milligrams of sulfadimethoxine.

Dogs

Indication
It is intended for use in the treatment of sulfonamide susceptible bacterial infections in dogs and enteritis associated with coccidiosis.
Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations
For use only by or on the order of a licensed veterinarian.

Cats

Indication
It is intended for use in the treatment of sulfonamide susceptible bacterial infections.
Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations
For use only by or on the order of a licensed veterinarian.

Bactrovet Tablets 250 mg

SPL · SPL

FDA Structured Product Label

Bactrovet Tablets 250 mg

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Sponsor
Intervet, Inc.
NADA
12087
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
No specifications are included in the CFR for this product.

Dogs

Indication
Treatment of sulfadimethoxine-susceptible bacterial infections.
Dosage
12.5 to 25 milligrams per pound body weight.
Limitations
Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

Cats

Indication
Treatment of sulfadimethoxine-susceptible bacterial infections.
Dosage
12.5 to 25 milligrams per pound body weight.
Limitations
Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

Sulfadimethoxine Soluble Powder

SPL · SPL

FDA Structured Product Label

Sulfadimethoxine Soluble Powder

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Sponsor
First Priority, Inc.
ANADA
200-443
Status
RX
Form
Soluble Powder
Route
Oral
Species
Beef And Dairy • Growing • Broilers • Replacements
Composition / specifications
Each 107 gram packet contains 3.34 oz (94.6 g) of sulfadimethoxine in the form of soluble sodium salt and disodium edetate.

Chickens (broiler and replacement)

Indication
For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05%) grams per gallon to prepare a drench or drinking water (contents of packet diluted to 50 gallons of water). Treat for 6 consecutive days.
Limitations

Do not administer to chickens over 16 weeks (112 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Indication

Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)

Indication
For the treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025%) grams per gallon to prepare a drench or drinking water (contents of the packet diluted to 100 gallons of water). Treat for 6 consecutive days.
Limitations

Do not administer to turkeys over 24 weeks (168 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Indication

Treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)

Indication
For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine, and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Dosage
Administer 25 mg/lb the first day followed by 12.5 mg/lb/day for 4 consecutive days.
Limitations

During treatment period, make certain that animals maintain adequate water Intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Indication

Treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Soluble Powder SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Sulfadimethoxine Soluble Powder. Use the source link for the full official labeling record.

Sulfadimethoxine SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Sulfadimethoxine. Use the source link for the full official labeling record.

Albon SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Albon. Use the source link for the full official labeling record.

Albon Bolus SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Albon Bolus. Use the source link for the full official labeling record.

DI-METHOX SPL

SPL · Structured Product Label

FDA Structured Product Label XML for DI-METHOX. Use the source link for the full official labeling record.

Albon SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Albon. Use the source link for the full official labeling record.

SULFASOL SPL

SPL · Structured Product Label

FDA Structured Product Label XML for SULFASOL. Use the source link for the full official labeling record.

Sulfadimethoxine Concentrated Solution 12.5% SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Sulfadimethoxine Concentrated Solution 12.5%. Use the source link for the full official labeling record.

SULFADIMETHOXINE 40% SPL

SPL · Structured Product Label

FDA Structured Product Label XML for SULFADIMETHOXINE 40%. Use the source link for the full official labeling record.

Sulforal SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Sulforal. Use the source link for the full official labeling record.

SulfaMed SPL

SPL · Structured Product Label

FDA Structured Product Label XML for SulfaMed. Use the source link for the full official labeling record.

SulfaMed SPL

SPL · Structured Product Label

FDA Structured Product Label XML for SulfaMed. Use the source link for the full official labeling record.

Sulfadimethoxine SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Sulfadimethoxine. Use the source link for the full official labeling record.

A200238_Orig_07_28_1998.pdf

FOI · FOI

A200251_Orig_8_03_1998.pdf

FOI · FOI

A200038_Orig_05_25_1993.pdf

FOI · FOI

UCM388201.pdf

FOI · FOI

A200031_Orig_6_17_1992.pdf

FOI · FOI

A200165_Org_12_4_1996.pdf

FOI · FOI

ucm059308.pdf

FOI · FOI

A200030 Orig_12_31_1992.pdf

FOI · FOI

A200192_Org_3_24_1997.pdf

FOI · FOI

A200177_Org_3_13_1997.pdf

FOI · FOI

ucm061683.pdf

FOI · FOI

UCM196111.pdf

FOI · FOI

ucm049548.pdf

FOI · FOI summary

UCM452233.pdf

FOI · FOI summary

N 100929_Orig_11_24_1989.pdf

FOI · FOI summary

N100929_Supp_8_5_1996.pdf

FOI · FOI summary

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Albon Albon Bolus DI-METHOX SULFADIMETHOXINE 40% SULFASOL SulfaMed Sulfadimethoxine Sulfadimethoxine Concentrated Solution 12.5% Sulfadimethoxine Soluble Powder Sulforal
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Beef, Beef And Dairy, Beef calves, Broilers, Broilers up to 16 weeks, Cat, Dairy, Dairy calves, Dairy heifers, Dog, Growing, Horse, Meat type, No Use Class Stated Or Implied, Replacements, Replacements up to 16 weeks age, Under 16 weeks
Rx/OTC: RX
Form/route: Bolus, Injection, Liquid, Liquid (Solution), Liquid (Suspension), Soluble Powder, Solution, Sustained Release Bolus, Tablet Intramuscular, Intravenous, Oral, Subcutaneous
Applications: ANADA 200-238 • ANADA 200-251 • ANADA 200-038 • NADA 43785 • NADA 15102 • ANADA 200-523 • NADA 41245 • NADA 31715 • ANADA 200-031 • ANADA 200-165 • ANADA 200-376 • ANADA 200-030 • NADA 98569 • ANADA 200-192 • ANADA 200-177 • NADA 46285 • NADA 31205 • ANADA 200-258 • NADA 93107 • NADA 12554 • NADA 37700 • NADA 12087 • ANADA 200-443
NDC: Packages 13985-574-24 17033-415-01 17033-428-03 23243-0410-5 46066-552-04 46066-555-93 Products 13985 17033 23243 46066 54771 58829
Documents: 12 (FOI: 12) • SPL: 24 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 31 Cat 11 View
Case summaries: 9 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. (Contraindication, High)
Top reaction signals
Hives (1) General pain (1) Gastric ulcer (1) Gagging (1) Found dead (1) Elevated blood urea nitrogen (1) Difficulty standing (1) Diarrhea (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200030 ANADA: 200031 ANADA: 200038 ANADA: 200165 ANADA: 200177 ANADA: 200192 ANADA: 200238 ANADA: 200251 ANADA: 200258 ANADA: 200376 ANADA: 200443 ANADA: 200523 NADA: 100929 NADA: 12087 NADA: 12554 NADA: 125933 NADA: 15102 NADA: 31205 NADA: 31715 NADA: 37700 NADA: 40209 NADA: 41245 NADA: 41984 NADA: 43785
Package NDC Product NDC Form / Route Status
13985-574-24 13985 -
13985-751-01 13985 -
15331-0103-1 15331 -
17033-415-01 17033 -
17033-428-03 17033 -
23243-0410-5 23243 -
23243-3700-7 23243 -
46066-081-11 46066 -
46066-552-04 46066 -
46066-555-93 46066 -
54771-1446-0 54771 -
54771-8431-1 54771 -
54771-8432-1 54771 -
54771-8433-1 54771 -
54771-8433-2 54771 -
54771-8435-1 54771 -
54771-8435-2 54771 -
54771-8449-1 54771 -
54771-8450-1 54771 -
54771-8450-2 54771 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Sulfadimethoxine Soluble Powder SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Sulfadimethoxine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Albon SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Albon Bolus SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • DI-METHOX SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Albon SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • SULFASOL SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Sulfadimethoxine Concentrated Solution 12.5% SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • SULFADIMETHOXINE 40% SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Sulforal SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • SulfaMed SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • SulfaMed SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Sulfadimethoxine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • A200251_Orig_8_03_1998.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200251
  • A200238_Orig_07_28_1998.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200238
  • ucm049548.pdf • FOI summary • Official • June 17, 2025
    FDA FOI summary for application 40209
  • A200038_Orig_05_25_1993.pdf • FOI summary • Official • July 3, 2024
    FDA FOI summary for application 200038
  • UCM452233.pdf • FOI summary • Official • Dec. 27, 2022
    FDA FOI summary for application 125933
  • UCM388201.pdf • FOI summary • Official • Dec. 16, 2022
    FDA FOI summary for application 200523
  • A200031_Orig_6_17_1992.pdf • FOI summary • Official • March 3, 2022
    FDA FOI summary for application 200031
  • A200165_Org_12_4_1996.pdf • FOI summary • Official • May 22, 2020
    FDA FOI summary for application 200165
  • ucm059308.pdf • FOI summary • Official • Oct. 2, 2018
    FDA FOI summary for application 200376
  • A200030 Orig_12_31_1992.pdf • FOI summary • Official • July 2, 2018
    FDA FOI summary for application 200030
  • N 100929_Orig_11_24_1989.pdf • FOI summary • Official • July 12, 2017
    FDA FOI summary for application 100929
  • N100929_Supp_8_5_1996.pdf • FOI summary • Official • July 12, 2017
    FDA FOI summary for application 100929
  • A200192_Org_3_24_1997.pdf • FOI summary • Official • May 22, 2017
    FDA FOI summary for application 200192
  • A200177_Org_3_13_1997.pdf • FOI summary • Official • May 19, 2017
    FDA FOI summary for application 200177
  • ucm061683.pdf • FOI summary • Official • Jan. 3, 2017
    FDA FOI summary for application 200258
  • UCM196111.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200443

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 73 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Lack of efficacy (protozoa) - C… (Clinical, 2026-04-11)
  • contraindications: Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for… (Official, 2026-04-12)
  • contraindications: Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for… (Official, 2026-04-11)
  • contraindications: Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for… (Official, 2026-02-12)
  • dosage_forms: Solution (Official, 2026-05-05)
  • dosage_forms: Solution (Official, 2026-05-03)
  • dosage_forms: Solution (Official, 2026-05-02)
  • dosage_forms: Solution (Official, 2026-04-29)
  • dosage_forms: Solution (Official, 2026-04-28)
  • dosage_forms: Solution (Official, 2026-04-27)
  • dosage_forms: Solution (Official, 2026-04-26)
  • dosage_forms: Solution (Official, 2026-04-25)
  • dosage_forms: Solution (Official, 2026-04-22)
  • indications: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-Producing Turkeys- Use fo… (Official, 2026-05-05)
  • indications: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-Producing Turkeys- Use fo… (Official, 2026-05-03)
  • indications: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-Producing Turkeys- Use fo… (Official, 2026-05-02)
  • indications: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-Producing Turkeys- Use fo… (Official, 2026-04-29)
  • indications: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-Producing Turkeys- Use fo… (Official, 2026-04-28)
  • indications: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-Producing Turkeys- Use fo… (Official, 2026-04-27)
  • indications: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-Producing Turkeys- Use fo… (Official, 2026-04-26)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Sulfasol Soluble Powder
RX
Sulfadimethoxine
Soluble Powder Oral
Dechra Veterinary Products LLC ANADA 200-238 Approved Feb 27, 2026
Sulforal®
RX
Sulfadimethoxine
Liquid (Solution) Oral
Dechra Veterinary Products LLC ANADA 200-251 Approved Feb 27, 2026
Di-Methox Injection 40%
RX
Sulfadimethoxine
Liquid (Solution) Intravenous
Huvepharma EOOD ANADA 200-038 Approved Jul 3, 2024
Albon Oral Suspension 5%
RX
Sulfadimethoxine
Liquid (Suspension) Oral
Zoetis Inc. NADA 43785 Approved May 22, 2023
Albon® Tablets
RX
Sulfadimethoxine
Tablet Oral
Zoetis Inc. NADA 15102 Approved May 22, 2023
SulfaMed®
RX
Sulfadimethoxine
Injection Intravenous
Bimeda Animal Health Limited ANADA 200-523 Approved Dec 16, 2022
Albon®
RX
Sulfadimethoxine
Liquid Intravenous, Subcutaneous
Zoetis Inc. NADA 41245 Approved Dec 5, 2022
Albon® or Agribon®
RX
Sulfadimethoxine
Bolus Oral
Zoetis Inc. NADA 31715 Approved Nov 30, 2022
DI-METHOX®
RX
Sulfadimethoxine
Soluble Powder Oral
Huvepharma EOOD ANADA 200-031 Approved Mar 3, 2022
Sulfadimethoxine Concentrated Solution 12.5%
RX
Sulfadimethoxine
Liquid (Solution) Oral
Cronus Pharma Specialities India Private Ltd. ANADA 200-165 Approved May 22, 2020
Sulfamed-G®
RX
Sulfadimethoxine
Soluble Powder Oral
Bimeda Animal Health Limited ANADA 200-376 Approved Oct 2, 2018
DI-METHOX®
RX
Sulfadimethoxine
Solution Oral
Huvepharma EOOD ANADA 200-030 Approved Jul 2, 2018
Medacide-SDM Injection 10%
RX
Sulfadimethoxine
Liquid Subcutaneous, Intramuscular, Intravenous
Cronus Pharma Specialities India Private Ltd. NADA 98569 Approved Feb 1, 2018
Sulfadimethoxine 12.5% Oral Solution
RX
Sulfadimethoxine
Liquid (Solution) Oral
Huvepharma EOOD ANADA 200-192 Approved May 22, 2017
Sulfadimethoxine Injection 40%
RX
Sulfadimethoxine
Liquid Intravenous
Huvepharma EOOD ANADA 200-177 Approved May 19, 2017
Albon®
RX
Sulfadimethoxine
Soluble Powder Oral
Zoetis Inc. NADA 46285 Approved Jan 3, 2017
ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5%
RX
Sulfadimethoxine
Solution Oral
Zoetis Inc. NADA 31205 Approved Jan 3, 2017
Sulfadimethoxine Soluble Powder
RX
Sulfadimethoxine
Liquid (Solution) Oral
Phibro Animal Health Corp. ANADA 200-258 Approved Jan 3, 2017
Albon® S.R. (Sustained Release)
RX
Sulfadimethoxine
Sustained Release Bolus Oral
Zoetis Inc. NADA 93107 Approved Jun 1, 2016
Bactrovet Injectable
RX
Sulfadimethoxine
Mallinckrodt Veterinary, Inc. NADA 12554 W Jun 1, 2016
Bactrovet Oral Suspension 12.5%
RX
Sulfadimethoxine
Liquid Oral
Intervet, Inc. NADA 37700 Approved Jun 1, 2016
Bactrovet Tablets 250 mg
RX
Sulfadimethoxine
Tablet Oral
Intervet, Inc. NADA 12087 Approved Jun 1, 2016
Sulfadimethoxine Soluble Powder
RX
Sulfadimethoxine
Soluble Powder Oral
First Priority, Inc. ANADA 200-443 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon. The powder is used to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon. The powder is used to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. The powder is used to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12 percent (3.75 gram per ounce) sulfadimethoxine.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
The oral solution is administered as a cattle drench or diluted as directed to prepare drinking water for treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Each mL contains 400 mg sulfadimethoxine
Cattle
Indication

For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus), sensitive to sulfadimethoxine.

Dosage

To be administered in amounts to provide 25 mg/lb (55 mg/kg) for the initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours. Must be administered only by the intravenous route in cattle. Length of treatment depends on the clinical response. In most cases treatment for 3-5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of the drug contains 50 milligrams of sulfadimethoxine.
Cats
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dogs
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs.

Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
No specifications are included in the CFR for this product.
Dogs
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs.






Dosage

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Dosage

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
400 mg/mL
Label highlights
Indication
For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine
Dosage
Intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Horse, Not For Meat Production • No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine injection containing 400 milligrams per milliliter.
Horses
Indication
For the treatment of respiratory disease caused by Streptococcus equi (strangles).
Dosage
It is administered by intravenous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours until the patient is asymptomatic for 48 hours.
Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs
Indication
For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the treatment of canine bacterial enteritis associated with coccidiosis and canine Salmonellosis.
Dosage
It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.
Limitations
Federal law restricts this drug to use by or on the order of a veterinarian.
Cats
Indication
For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine.
Dosage
It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.
Limitations
Federal law restricts this drug to use by or on the order of a veterinarian.
Cattle
Indication
For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.
Dosage
It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations
Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. Tissue damage may result from perivascular infiltration. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Cattle
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

Dosage
1.25 to 2.5 grams per 100 pounds body weight. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
107 g (3.77 oz.) pouch: each packet contains 3.34 oz. (94.6 g) of sulfadimethoxine in the form of the soluble salt and disodium edetate. 535 g (18.87 oz.) pouch: each packet contains 16.8 oz. (473 g) of sulfadimethoxine in the form of the soluble salt and disodium edetate.
Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 (0.05 percent) grams of powder per gallon of water in drinking water or as a drench. Administer for 6 consecutive days.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)
Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks (168 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.025 percent) as regular drinking water. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. The oral solution is administered as a drench or diluted as directed to prepare drinking water.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12 percent (3.75 gram per ounce) sulfadimethoxine.
Chickens (broiler and replacements)
Indication

For treatment of outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams/gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (growing)
Indication

For growing turkeys: For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams/gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age.Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams/gallon (0.031-0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Replacements up to 16 weeks age • Broilers up to 16 weeks
Composition / specifications
107 g (3.77 oz) pouch: each packet contains 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate. 535 g (18.87 oz) pouch: each packet contains 16.8 oz (473 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate. 25 lb (11.34 kg) pail: 3 scoops contain 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams of powder per gallon to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef cattle)
Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. Federal law prohibits the extralabel use of this product in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Beef calves • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12.5 percent (3.75 gram per ounce) sulfadimethoxine.
Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks (168 days) of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.025 percent) as regular drinking water. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

The oral solution is administered as a drench or diluted as directed to prepare drinking water. Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams per gallon of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine containing 100 milligrams per milliliter.
Dogs
Indication
It is used or intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs.
Dosage
It is administered by subcutaneous, intramuscular or intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours thereafter. Continue treatment until the animal is free from symptoms for 48 hours.
Limitations
For use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Growing • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each ounce of solution contains (3.75 grams (12.5 percent) sulfadimethoxine.
Turkeys (growing)
Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication.Withdraw 5 days before slaughter.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) ofdrinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. 

Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine injection containing 400 milligrams per milliliter
Cattle
Indication
For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.
Dosage
It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations
Tissue damage may result from perivascular infiltration. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine (as the sodium salt).
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Cattle (dairy calves, dairy heifers, and beef cattle)
Indication

Treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each ounce of solution contains (3.75 grams (12.5 percent) sulfadimethoxine.
Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Turkeys (growing)
Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Administer as sole source of drinking water and sulfonamide medication. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Administer as sole source of drinking water and sulfonamide medication. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

 Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, non-lactating
Composition / specifications
12.5-gram-sustained-release bolus.
Cattle (beef and nonlactating dairy)
Indication
Treatment of shipping fever complex and bacterial pneumonia associated with organisms such as Pasteurella species sensitive to sulfadimethoxine; calf diphtheria and foot rot associated with Sphaerophorus necrophorus.
Dosage
Administer one bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight.
Limitations
Do not repeat treatment for 7 days. Do not use in lactating dairy cattle. Do not administer within 12 days of slaughter. During treatment make certain that animals maintain adequate water intake. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of the drug contains 50 milligrams of sulfadimethoxine.
Dogs
Indication
It is intended for use in the treatment of sulfonamide susceptible bacterial infections in dogs and enteritis associated with coccidiosis.
Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations
For use only by or on the order of a licensed veterinarian.
Cats
Indication
It is intended for use in the treatment of sulfonamide susceptible bacterial infections.
Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations
For use only by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
No specifications are included in the CFR for this product.
Dogs
Indication
Treatment of sulfadimethoxine-susceptible bacterial infections.
Dosage
12.5 to 25 milligrams per pound body weight.
Limitations
Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.
Cats
Indication
Treatment of sulfadimethoxine-susceptible bacterial infections.
Dosage
12.5 to 25 milligrams per pound body weight.
Limitations
Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Dairy • Growing • Broilers • Replacements
Composition / specifications
Each 107 gram packet contains 3.34 oz (94.6 g) of sulfadimethoxine in the form of soluble sodium salt and disodium edetate.
Chickens (broiler and replacement)
Indication
For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05%) grams per gallon to prepare a drench or drinking water (contents of packet diluted to 50 gallons of water). Treat for 6 consecutive days.
Limitations

Do not administer to chickens over 16 weeks (112 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Indication

Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)
Indication
For the treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025%) grams per gallon to prepare a drench or drinking water (contents of the packet diluted to 100 gallons of water). Treat for 6 consecutive days.
Limitations

Do not administer to turkeys over 24 weeks (168 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Indication

Treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine, and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Dosage
Administer 25 mg/lb the first day followed by 12.5 mg/lb/day for 4 consecutive days.
Limitations

During treatment period, make certain that animals maintain adequate water Intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Indication

Treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

Treatment of sulfadimethoxine-susceptible bacterial infections. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Dog Drooling (1) • Cat Diarrhea (1) • Cat Blood in vomit (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hives (1) • Dog Chewing - pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Inappetence (1) • Dog Hypoproteinaemia (1) • Dog Hyperthermia (1) • Cat General pain (1) • Dog Gastric ulcer (1) • Dog
Show more (19)
Gagging (1) • Dog Found dead (1) • Dog Foaming at the mouth (1) • Cat Elevated haematocrit (1) • Dog Elevated blood urea nitrogen (1) • Dog Ear infection NOS (1) • Dog Ear canal inflammation (1) • Dog Disorientation (1) • Cat Difficulty standing (1) • Dog Dehydration (1) • Dog Decreased blood urea nitrogen (BUN) or creatinine (1) • Dog Death (1) • Dog Crying (1) • Dog Cough, productive (1) • Dog Collapse NOS (1) • Dog Blood in faeces (1) • Dog Anaphylaxis (1) • Dog Anaemia NOS (1) • Dog Abdominal pain (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Retriever - Golden, Male, 2 month, 6.622 kilogram • Drug: MSK, Suspension, Oral, Dose: 7.25 mL per animal, Frequency: 1 per day • Reactions: Weakness, Not eating, Lying down, Inappropriate urination, Difficulty standing… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-075245
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 2.00 Month
  • Weight: 6.622 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Suspension
  • Dose: 7.25 mL per animal
  • Frequency: 1 per day
Reactions Reported:
Weakness Not eating Lying down Inappropriate urination Difficulty standing Walking slowly Collapse NOS Pain NOS Sneezing Cough, productive Involuntary urination Unable to walk Leucocytosis NOS Anaemia NOS Decreased blood urea nitrogen (BUN) or creatinine Abdominal pain Gastric ulcer Seizure NOS Death Lack of efficacy - NOS
Outcomes: Died

Dog, ['Bulldog - French', 'Pug'], Female, 3 month, 2.46 kilogram • Drug: MSK, Unknown • Reactions: Behavioral disorder (unspecified), Vocalisation, Pain NOS, Pacing, Found dead… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-073865
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 3.00 Month
  • Weight: 2.460 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Behavioral disorder (unspecified) Vocalisation Pain NOS Pacing Found dead Crying
Outcomes: Died

Dog, ['Bulldog - French', 'Pug'], Female, 2 month, 2.46 kilogram • Drug: MSK, Suspension, Oral, Dose: 2.70 mL per animal • Reactions: Crying, General pain, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-072856
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 2.00 Month
  • Weight: 2.460 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Suspension
  • Dose: 2.70 mL per animal
Reactions Reported:
Crying General pain Death
Outcomes: Died

Dog, Beagle, Male, 2 month, 4.019 kilogram • Drug: MSK, Suspension, Oral, Dose: 4.50 mL per animal, Frequency: 24 per hour • Reactions: Hives, Chewing - pruritus • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-068702
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 2.00 Month
  • Weight: 4.019 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Suspension
  • Dose: 4.50 mL per animal
  • Frequency: 24 per hour
Reactions Reported:
Hives Chewing - pruritus
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 14 week, 2.177 kilogram • Drug: MSK, Suspension, Oral • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-068713
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Week
  • Weight: 2.177 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Suspension
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS
Outcomes: Ongoing

Dog, Shepherd Dog - Australian, Female, 3 month • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - hookworm, Diarrhea, Vomiting • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-069347
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.00 Month
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (endoparasite) - hookworm Diarrhea Vomiting
Outcomes: Outcome Unknown

Cat, Domestic Longhair, Female, 3 month, 1.098 kilogram • Drug: MSK, Suspension, Oral, Dose: 1.20 mL per animal, Frequency: 1 per day • Reactions: Not eating, Not drinking, Respiratory tract infection NOS, Diarrhea, Vomiting… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-064137
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.00 Month
  • Weight: 1.098 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Suspension
  • Dose: 1.20 mL per animal
  • Frequency: 1 per day
Reactions Reported:
Not eating Not drinking Respiratory tract infection NOS Diarrhea Vomiting Weight loss Unkempt hair coat
Outcomes: Ongoing

Cat, Cat (other), Unknown, 2 week, 0.136 kilogram • Drug: MSK, Suspension, Oral, Dose: 50 Milligram per kilogram • Reactions: Lack of efficacy (protozoa) - Coccidia, Medication error NOS, Underdose • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-062987
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Unknown
  • Age: 2.00 Week
  • Weight: 0.136 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Suspension
  • Dose: 50 Milligram per kilogram
Reactions Reported:
Lack of efficacy (protozoa) - Coccidia Medication error NOS Underdose
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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