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Roxee Medication Guide

Tulathromycin

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete Livestock/food-animal use Rx required Liquid (Solution) Multiple FDA labelers Official label facts Owner quick guide first
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Tulathromycin

Tulathromycin

Drug type: Food-animal record • Branded profile • Livestock/food-animal use

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Approval status: Food-animal or livestock record. This source record is for livestock or food-animal use, not a dog/cat medication profile. Food-animal rules, withdrawal intervals, and residue restrictions may apply.

Medication Snapshot

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

Tulathromycin

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis . For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers. Species commonly shown: Both, Suckling Calves, Dairy Calves, Veal Calves.

Generic name
Tulathromycin
Brand names
Draxxin®, Draxxin® 25 Injectable Solution, MACROSYN™, Increxxa™ 25
Manufacturer
Multiple FDA labelers
Species
Both, Suckling Calves, Beef, Dairy
Dosage forms
Liquid (Solution), Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Draxxin® Draxxin® 25 Injectable Solution MACROSYN™ Increxxa™ 25 Increxxa™ Tulissin® 25 Tulissin® 100 TULAVEN™ 100 TULAVEN™ 25 AROVYN™ Tulieve® RESPIRmycin™ Tulathromycin Injection RESPIRmycin™ 25 Tulaject™ 100 Tulaject™ Tulieve Draxxin 25 Arovyn Increxxa VACASAN RESPIRmycin RESPIRmycin 25 Draxxin Tulissin 100 VACASAN 25 Increxxa 25 Tulissin 25 TULATHROMYCIN Macrosyn
Dosage forms
Liquid (Solution) Injectable Solution

Indications / Uses

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis . For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

Warnings / Contraindications

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

  • Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of efficacy - NOS.

FAQ

Both, Suckling Calves, Dairy Calves, Veal Calves, Beef, Dairy, non-lactating, Beef And Non-Lactating Dairy, Dairy calves, Suckling calves, Veal calves

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Injectable Solution

Related Conditions

Conjunctivitis Pneumonia (aspiration, bacterial, viral)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis and Mycoplasma hyopneumoniae ; and for control of SRD associa...

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:

  • Do not inject more than 4 mL per injection site
  • For use in suckling calves, dairy calves, veal calves, and swine
  • Not for use in ruminating cattle
  • Not for use in Chickens or Turkeys
  • Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian
  • Do not inject more than 11.5 mL per injection site
  • Vocalisation (1 reports)
  • trouble breathing (1 reports)
  • very low energy (1 reports)

When to call the vet:

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

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?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Tulathromycin; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2024-US-013392
Safety signal coverage Reported signals

22 tracked reaction signals; 18 reported cases; 14 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2024-US-013392
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2024-US-013392
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Vocalisation (1 reports), Trouble breathing (dyspnea) (1 reports), Tiredness (lethargy) (1 reports), Pneumothorax (1 reports), Panting (1 reports)

Body systems represented Signal grouping

Neurologic (3), Effectiveness (2), Other (17)

Species and breed lens

Species represented in reports Species lens

Dog (12 reports), Cat (10 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Tulathromycin fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Do not inject more than 4 mL per injection site, For use in suckling calves, dairy calves, veal calves, and swine, Not for use in ruminating cattle, Not for use in Chickens or Turkeys, Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian

Call sooner if Escalation

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

Bottom line: Use this Tulathromycin brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2024-US-013392 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. FOI · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
Safety & side effects

Side effects to monitor:

  • Do not inject more than 4 mL per injection site
  • For use in suckling calves, dairy calves, veal calves, and swine
  • Not for use in ruminating cattle
  • Not for use in Chickens or Turkeys
  • Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian

Most reported reactions:

  • Vocalisation (1 reports)
  • Trouble breathing (dyspnea) (1 reports)
  • Tiredness (lethargy) (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Beef, Beef And Non-Lactating Dairy, Dairy, Dairy calves, Suckling Calves, Suckling calves, Veal calves
Indication / use
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis and Mycoplasma hyopn…
Form / route / dose
Form: Injectable Solution, Liquid (Solution)
Route: Intramuscular, Subcutaneous
Confirm product label and patient-specific plan.
Warnings
  • High: Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not …
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Injectable Solution, Liquid (Solution)
Identifiers:
ANADA: 200657 ANADA: 200665 ANADA: 200666 ANADA: 200668 ANADA: 200669 ANADA: 200711 ANADA: 200712 ANADA: 200715 ANADA: 200723 ANADA: 200730 ANADA: 200742 ANADA: 200745 ANADA: 200773 ANADA: 200774 NADA: 141244 NADA: 141349 NADA: 141543 NDC Package: 0061-6607-02 NDC Package: 0061-6607-03 NDC Package: 0061-6607-04
Source metadata:

Warnings / Contraindications

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

  • High: Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.
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
22
Reported cases
18
Serious reports
14
Species represented
2
Grouped by Body System
Neurologic (3) · Tiredness (lethargy), Neurological signs NOS, Lethargy (see also Central nervous system depression in 'Neurological') Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (bacteria) - NOS Other (17) · Vocalisation, Trouble breathing (dyspnea), Pneumothorax
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Other 1 Dog 1
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Neurologic 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (12) Cat (10)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Cat Serious - 1
Other Dog Serious - 1
Neurologic Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Neurologic Cat Serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Neurologic Dog Unknown - -
Other Cat Unknown - -
Other Cat Unknown - -
Other Cat Unknown - -
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Draxxin® SPL · SPL Tulathromycin Injection SPL · SPL Tulaject™ SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

30

FOI

24

Draxxin®

SPL · SPL

Open original
FDA Structured Product Label

Draxxin®

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
141-244
Status
RX
Form
Liquid (Solution)
Route
Intramuscular, Subcutaneous
Species
Suckling Calves • Beef • Dairy
Composition / specifications
Each milliliter of solution contains 100 milligrams (mg) tulathromycin.

Swine

Indication
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis and Mycoplasma hyopneumoniae; and for control of SRD associated with Actinobacillus pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.
Dosage
Administer 2.5 mg per kilogram (0.25 mL/22 lb) body weight as a single intramuscular injection in the neck.
Limitations
Do not inject more than 2.5 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Beef and Non-Lactating Dairy)

Indication
For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Indication
For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis; and for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Suckling Calves, Dairy Calves, and Veal Calves)

Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tulathromycin Injection

SPL · SPL

Open original
FDA Structured Product Label

Tulathromycin Injection

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

Sponsor
Hikma Pharmaceuticals USA, Inc.
ANADA
200-742
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL

Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves and veal calves

Indication

BRD – Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – Tulathromycin Injection is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – Tulathromycin Injection is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Suckling Calves, Dairy Calves, and Veal Calves

BRD – Tulathromycin Injection is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

Tulathromycin Injection is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Tulaject™

SPL · SPL

Open original
FDA Structured Product Label

Tulaject™

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

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-774
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Suckling Calves
Composition / specifications
25 mg of tulathromycin/mL

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) body weight (BW). Do not inject more than 4 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) BW. Do not inject more than 11.5 mL per injection site.

Tulaject™ 100

SPL · SPL

Open original
FDA Structured Product Label

Tulaject™ 100

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

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-773
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
IBK- For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis
Foot Rot- For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

RESPIRmycin™ 25

SPL · SPL

Open original
FDA Structured Product Label

RESPIRmycin™ 25

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

Sponsor
Parnell Technologies Pty. Ltd.
ANADA
200-745
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves
Composition / specifications
25 mg of tulathromycin/mL

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dose of 2.5 mg/kg (1 mL/22 lb BW. Do not inject more than 11.5 mL per injection site.

RESPIRmycin™

SPL · SPL

Open original
FDA Structured Product Label

RESPIRmycin™

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

Sponsor
Parnell Technologies Pty. Ltd.
ANADA
200-730
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Beef And Non-Lactating Dairy • Dairy calves • Suckling calves • Veal calves
Composition / specifications
100 mg of tulathromycin/mL

Beef and non-lactating dairy cattle

Indication

BRD – For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling calves, dairy calves, and veal calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Tulieve®

SPL · SPL

Open original
FDA Structured Product Label

Tulieve®

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

Sponsor
Norbrook Laboratories, Ltd.
ANADA
200-723
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

AROVYN™

SPL · SPL

Open original
FDA Structured Product Label

AROVYN™

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

Sponsor
Intervet, Inc.
ANADA
200-715
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.


Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Increxxa™ 25

SPL · SPL

Open original
FDA Structured Product Label

Increxxa™ 25

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

Sponsor
Elanco US Inc.
ANADA
200-665
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves
Composition / specifications
25 mg tulathromycin/mL

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

TULAVEN™ 100

SPL · SPL

Open original
FDA Structured Product Label

TULAVEN™ 100

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

Sponsor
Ceva Sante Animale
ANADA
200-711
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves • Beef And Non-Lactating Dairy • Dairy calves
Composition / specifications
100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

BRD: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

TULAVEN™ 25

SPL · SPL

Open original
FDA Structured Product Label

TULAVEN™ 25

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

Sponsor
Ceva Sante Animale
ANADA
200-712
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Suckling Calves
Composition / specifications
25 mg/mL of tulathromycin

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg(1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Tulissin® 100

SPL · SPL

Open original
FDA Structured Product Label

Tulissin® 100

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

Sponsor
Virbac AH, Inc.
ANADA
200-669
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

BRD: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Tulissin® 25

SPL · SPL

Open original
FDA Structured Product Label

Tulissin® 25

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

Sponsor
Virbac AH, Inc.
ANADA
200-668
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves
Composition / specifications
25 mg tulathromycin/mL

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Suckling calves, dairy calves, and veal calves

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Increxxa™

SPL · SPL

Open original
FDA Structured Product Label

Increxxa™

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

Sponsor
Elanco US Inc.
ANADA
200-666
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

MACROSYN™

SPL · SPL

Open original
FDA Structured Product Label

MACROSYN™

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 Ltd.
ANADA
200-657
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL

Beef and Non-Lactating Dairy Cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Suckling Calves, Dairy Calves, and Veal Calves

Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Swine

Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb.) BW. Do not inject more than 2.5 mL per injection site.

Draxxin® 25 Injectable Solution

SPL · SPL

Open original
FDA Structured Product Label

Draxxin® 25 Injectable 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
Zoetis Inc.
NADA
141-349
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Suckling Calves
Composition / specifications
25 mg/mL

Swine

Indication
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
Dosage
Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/ kg (1 mL/22 lb) Body Weight (BW).
Limitations
Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Cattle (Calves)

Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
Dosage
Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW).
Limitations
Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

VACASAN 25 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for VACASAN 25. Use the source link for the full official labeling record.

Tulissin 100 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Tulissin 100. Use the source link for the full official labeling record.

Draxxin SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Draxxin. Use the source link for the full official labeling record.

RESPIRmycin 25 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for RESPIRmycin 25. Use the source link for the full official labeling record.

Macrosyn SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Macrosyn. Use the source link for the full official labeling record.

Arovyn SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Arovyn. Use the source link for the full official labeling record.

Increxxa 25 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Increxxa 25. Use the source link for the full official labeling record.

Increxxa SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Increxxa. Use the source link for the full official labeling record.

Draxxin 25 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Draxxin 25. Use the source link for the full official labeling record.

Tulieve SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Tulieve. Use the source link for the full official labeling record.

VACASAN SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for VACASAN. Use the source link for the full official labeling record.

Tulissin 25 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Tulissin 25. Use the source link for the full official labeling record.

RESPIRmycin SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for RESPIRmycin. Use the source link for the full official labeling record.

TULATHROMYCIN SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for TULATHROMYCIN. Use the source link for the full official labeling record.

UCM421912.pdf

FOI · FOI

Open original

UCM196106.pdf

FOI · FOI

Open original

N141244 Supp_8_28_2008.pdf

FOI · FOI

Open original

ucm051495.pdf

FOI · FOI

Open original

ucm051496.pdf

FOI · FOI

Open original

ucm118064.pdf

FOI · FOI

Open original

ucm118061.pdf

FOI · FOI

Open original

FOI Summary oA 200-742 Approved February 25, 2025.pdf

FOI · FOI

Open original

FOI Summary oA 200-774 Approved September 10, 2024.pdf

FOI · FOI

Open original

FOI Summary oA 200-773 Approved September 5, 2024.pdf

FOI · FOI

Open original

FOI Summary oA 200-745 Approved March 21, 2023.pdf

FOI · FOI

Open original

FOI Summary oA 200-730 Approved November 4, 2022.pdf

FOI · FOI

Open original

FOI Summary oA 200-723 Approved March 23, 2022.pdf

FOI · FOI

Open original

FOI Summary oA 200-715 Approved February 9, 2022.pdf

FOI · FOI

Open original

FOI Summary oA 200-665 Approved February 7, 2022.pdf

FOI · FOI

Open original

FOI Summary oA 200-711 Approved November 1, 2021.pdf

FOI · FOI

Open original

FOI Summary oA 200-712 Approved November 3, 2021.pdf

FOI · FOI

Open original

FOI Summary oA 200-669 Approved November 15, 2021.pdf

FOI · FOI

Open original

FOI Summary oA 200-668 Approved November 12, 2021.pdf

FOI · FOI

Open original

FOI Summary oA 200-666 Approved February 18, 2021.pdf

FOI · FOI

Open original

FOI Summary oA 200-657 Approved February 18, 2021.pdf

FOI · FOI

Open original

UCM436589.pdf

FOI · FOI

Open original

UCM374308.pdf

FOI · FOI

Open original

FOI Summary oN 141-543 Approved June 1, 2021.pdf

FOI · FOI summary

Open original
Source metadata:
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
  • Reference facts: Source Roxee | Refreshed Jun 23, 2026, 10:05 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 23, 2026, 10:44 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed May 15, 2026, 10:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 23, 2026, 10:45 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Arovyn Draxxin Draxxin 25 Increxxa Increxxa 25 Macrosyn RESPIRmycin RESPIRmycin 25 TULATHROMYCIN Tulieve Tulissin 100 Tulissin 25 VACASAN VACASAN 25
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both • FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Dairy, Dairy calves, Suckling Calves, Suckling calves, Veal calves
Rx/OTC: RX
Form/route: Injectable Solution, Liquid (Solution) • Intramuscular, Subcutaneous
Applications: NADA 141-244 • ANADA 200-742 • ANADA 200-774 • ANADA 200-773 • ANADA 200-745 • ANADA 200-730 • ANADA 200-723 • ANADA 200-715 • ANADA 200-665 • ANADA 200-711 • ANADA 200-712 • ANADA 200-669 • ANADA 200-668 • ANADA 200-666 • ANADA 200-657 • NADA 141-349
NDC: Packages 0061-6607-02 0061-6607-03 0061-6607-04 0061-6607-05 23243-2825-1 23243-2825-2 • Products 0061 23243 51311 54771 55529 58198
Documents: 23 (FOI: 23) • SPL: 16 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: 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
  • Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Vocalisation (1) Trouble breathing (dyspnea) (1) Tiredness (lethargy) (1) Pneumothorax (1) Panting (1) Neurological signs NOS (1) Injection site reaction NOS (1) Head bobbing (1)

Identifiers & Packages

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

Identifiers
ANADA: 200657 ANADA: 200665 ANADA: 200666 ANADA: 200668 ANADA: 200669 ANADA: 200711 ANADA: 200712 ANADA: 200715 ANADA: 200723 ANADA: 200730 ANADA: 200742 ANADA: 200745 ANADA: 200773 ANADA: 200774 NADA: 141244 NADA: 141349 NADA: 141543 NDC Package: 0061-6607-02 NDC Package: 0061-6607-03 NDC Package: 0061-6607-04 NDC Package: 0061-6607-05 NDC Package: 23243-2825-1 NDC Package: 23243-2825-2 NDC Package: 23243-5282-1
Package NDC Product NDC Form / Route Status
0061-6607-02 0061 -
0061-6607-03 0061 -
0061-6607-04 0061 -
0061-6607-05 0061 -
23243-2825-1 23243 -
23243-2825-2 23243 -
23243-5282-1 23243 -
23243-5282-2 23243 -
23243-5282-5 23243 -
23243-5282-6 23243 -
51311-002-10 51311 -
51311-002-25 51311 -
51311-006-10 51311 -
51311-006-25 51311 -
51311-006-50 51311 -
51311-006-51 51311 -
54771-2155-1 54771 -
54771-2155-2 54771 -
54771-2155-3 54771 -
54771-2155-4 54771 -

Enriched Documents

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

Data Sources & Change Log

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

Official 97 Clinical 61 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-23)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-22)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-22)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-21)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-20)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-13)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-12)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-12)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-11)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-11)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-10)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-08)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-07)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-06)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-05)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-04)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-03)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-02)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-01)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Clinical, 2026-06-01)
Recent Revisions
  • side_effects updated 2026-06-23 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-23 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-23 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-12 10:42 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
Draxxin®
RX
Tulathromycin
Liquid (Solution) • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 141-244 Approved May 14, 2026
Tulathromycin Injection
RX
Tulathromycin
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Hikma Pharmaceuticals USA, Inc. ANADA 200-742 Approved Feb 26, 2025
Tulaject™
RX
Tulathromycin
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-774 Approved Oct 1, 2024
Tulaject™ 100
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-773 Approved Oct 1, 2024
RESPIRmycin™ 25
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Parnell Technologies Pty. Ltd. ANADA 200-745 Approved Apr 3, 2023
RESPIRmycin™
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Parnell Technologies Pty. Ltd. ANADA 200-730 Approved Dec 1, 2022
Tulieve®
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Norbrook Laboratories, Ltd. ANADA 200-723 Approved Apr 1, 2022
AROVYN™
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Intervet, Inc. ANADA 200-715 Approved Mar 1, 2022
Increxxa™ 25
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Elanco US Inc. ANADA 200-665 Approved Mar 1, 2022
TULAVEN™ 100
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Ceva Sante Animale ANADA 200-711 Approved Dec 1, 2021
TULAVEN™ 25
RX
Tulathromycin
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Ceva Sante Animale ANADA 200-712 Approved Dec 1, 2021
Tulissin® 100
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Virbac AH, Inc. ANADA 200-669 Approved Dec 1, 2021
Tulissin® 25
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Virbac AH, Inc. ANADA 200-668 Approved Dec 1, 2021
Increxxa™
RX
Tulathromycin
Injectable Solution • Subcutaneous, Intramuscular
Label highlights
Official documents
Elanco US Inc. ANADA 200-666 Approved Mar 1, 2021
MACROSYN™
RX
Tulathromycin
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Bimeda Animal Health Ltd. ANADA 200-657 Approved Mar 1, 2021
Draxxin® 25 Injectable Solution
RX
Tulathromycin
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 141-349 Approved Apr 1, 2019

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: Suckling Calves • Beef • Dairy
Composition / specifications
Each milliliter of solution contains 100 milligrams (mg) tulathromycin.
Swine
Indication
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis and Mycoplasma hyopneumoniae; and for control of SRD associated with Actinobacillus pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.
Dosage
Administer 2.5 mg per kilogram (0.25 mL/22 lb) body weight as a single intramuscular injection in the neck.
Limitations
Do not inject more than 2.5 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cattle (Beef and Non-Lactating Dairy)
Indication
For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Indication
For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis; and for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not use in female dairy cattle 20 months of age or older. Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cattle (Suckling Calves, Dairy Calves, and Veal Calves)
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
Dosage
Administer 2.5 mg per kilogram (1.1 mL/100 lb) body weight as a single subcutaneous injection in the neck.
Limitations
Do not inject more than 10 mL per injection site. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves and veal calves
Indication

BRD – Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – Tulathromycin Injection is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – Tulathromycin Injection is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Suckling Calves, Dairy Calves, and Veal Calves

BRD – Tulathromycin Injection is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

Tulathromycin Injection is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves
Composition / specifications
25 mg of tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
IBK- For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis
Foot Rot- For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves
Composition / specifications
25 mg of tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dose of 2.5 mg/kg (1 mL/22 lb BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy • Dairy calves • Suckling calves • Veal calves
Composition / specifications
100 mg of tulathromycin/mL
Beef and non-lactating dairy cattle
Indication

BRD – For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling calves, dairy calves, and veal calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.


Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves
Composition / specifications
25 mg tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy • Dairy calves
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

BRD: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves
Composition / specifications
25 mg/mL of tulathromycin
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg(1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

BRD: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves
Composition / specifications
25 mg tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling calves, dairy calves, and veal calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb.) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves
Composition / specifications
25 mg/mL
Swine
Indication
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
Dosage
Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/ kg (1 mL/22 lb) Body Weight (BW).
Limitations
Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.
Cattle (Calves)
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
Dosage
Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW).
Limitations
Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis . For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

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

Neurologic
Tiredness (1) • Dog Neurological signs NOS (1) • Cat Tiredness (lethargy) • Dog

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (bacteria) - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Vocalisation (1) • Cat Trouble breathing (1) • Dog Pneumothorax (1) • Dog Panting (1) • Dog Overdose (1) • Dog
Show more (9)
Oral cavity disorder NOS (1) • Dog Injection site reaction NOS (1) • Dog Head bobbing (1) • Cat Elevated blood urea nitrogen (1) • Cat Elevated aspartate aminotransferase (1) • Cat Elevated alanine aminotransferase (1) • Cat Cutaneous emphysema (1) • Dog Coughing up blood (1) • Dog Blindness (1) • Cat

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.

No case-level openFDA reports are linked for this medication yet.

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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Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.