Skip to main content
Start triage

Start triage first, then route to emergency care.

Need urgent help? Start triage first, then route to emergency care.

Roxee Meds Catalog

Flunixin Meglumine

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

Both Catalog complete Livestock/food-animal use Rx required Top Dressing In Feed Multiple FDA labelers Official label facts Owner quick guide first

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:05 a.m.

These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
No safety reports linked
No refresh timestamp yet

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

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

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

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

Sources:
Image coming soon
Flunixin Meglumine

Flunixin Meglumine

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

Both Top Dressing In Feed Rx required 100% storefront ready

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.

Flunixin Meglumine

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia. For the control of pyrexia associated with swine respiratory disease. Species commonly shown: Both, Horse, Not For Meat Production, Beef, excluding breeding bulls.

Generic name
Flunixin Meglumine
Brand names
Banamine® Granules, Banamine® Banamine®-S, Banamine® Paste, Flu-Nix™
Manufacturer
Multiple FDA labelers
Species
Both, Horse, Not For Meat Production, Beef, excluding breeding bulls, Dairy, excluding dry dairy cows and breeding bulls
Dosage forms
Top Dressing In Feed, Injectable Solution, Paste, Liquid (Solution)
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Banamine® Granules Banamine® Banamine®-S Banamine® Paste Flu-Nix™ Flunixin Meglumine Injection Flunixin Meglumine Solution Flunazine™ Flunixin Injection - S Flunazine®-S Flunazine® Flunine™ Flunine-S™ Flunixin-S Banamine Prevail VetaMeg Flunixin Flunazine Flunine Flunixin Meglumine Flu-Nix Vetameg S Flunazine-S
Dosage forms
Top Dressing In Feed Injectable Solution Paste Liquid (Solution)

Indications / Uses

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia. For the control of pyrexia associated with swine respiratory disease.

Warnings / Contraindications

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depression in 'Neurological').

FAQ

Both, Horse, Not For Meat Production, Beef, excluding breeding bulls, Dairy, excluding dry dairy cows and breeding bulls, Calves, excluding veal calves, Beef And Dairy, No Use Class Stated Or Implied, Dairy, excluding dry cows

Yes. Roxee shows this as prescription-only.

Top Dressing In Feed, Injectable Solution, Paste, Liquid (Solution)

Related Conditions

Source Transparency

Add to My Pet's Meds

Choose a pet, confirm current or past, and optionally add reminder notes.

Sign in to save this medication to your pet profile.

Sign in to continue

Pet Owner Quick Guide

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

Used for:

For the control of pyrexia associated with swine respiratory disease.

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:

  • Not for use in horses intended for food
  • Do not slaughter for human consumption within 4 days of last treatment
  • A withdrawal period has not been established for use in preruminating calves
  • Do not use in calves to be processed for veal
  • Do not use in dry dairy cows
  • Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food
  • Approved only for intravenous administration in cattle
  • Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter
  • Swine must not be slaughtered for human consumption within 12 days of last treatment
  • very low energy (1 reports)
  • Surgical site disorder (1 reports)
  • Shaking (1 reports)

When to call the vet:

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

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

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

Side effects to monitor:

  • Not for use in horses intended for food
  • Do not slaughter for human consumption within 4 days of last treatment
  • A withdrawal period has not been established for use in preruminating calves
  • Do not use in calves to be processed for veal
  • Do not use in dry dairy cows

Most reported reactions:

  • Tiredness (lethargy) (1 reports)
  • Surgical site disorder (1 reports)
  • Shaking (1 reports)

Emergency warning signs:

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

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Injectable Solution, Liquid (Solution), Paste, Top Dressing In Feed
Identifiers:
ANADA: 200061 ANADA: 200124 ANADA: 200142 ANADA: 200387 ANADA: 200476 ANADA: 200489 ANADA: 200581 ANADA: 200781 ANADA: 200791 ANADA: 200828 NADA: 101479 NADA: 106616 NADA: 137409 NADA: 141299 NADA: 141312 NDC Package: 0061-0214-02 NDC Package: 0061-0851-03 NDC Package: 0061-0851-04 NDC Package: 0061-4305-01 NDC Package: 0061-4305-02
Source metadata:

Warnings / Contraindications

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by 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
32
Reported cases
32
Serious reports
26
Species represented
2
Grouped by Body System
Digestive (4) · Loss of appetite, Haemorrhagic diarrhoea, Diarrhea Neurologic (1) · Tiredness (lethargy) Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (ectoparasite) - tick NOS Other (25) · Surgical site disorder, Shaking, Reluctant to move
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (25) Cat (7)

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

Documents

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

6

SPL

41

FOI

23

A-200489-C-0073-NL-AA_PI_2.pdf

Official label / PI · Labeling

N-137409-C-0125-NL-AA_PI.pdf

Official label / PI · Labeling

A-200781-C-0017-NL-AA_PI.pdf

Official label / PI · Labeling

A-200476-R-0049-CS-AA_PI.pdf

Official label / PI · Labeling

101-479

Official label / PI · EA

101-479

Official label / PI · FONSI

Flunazine®-S

SPL · SPL

FDA Structured Product Label

Flunazine®-S

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

Sponsor
Bimeda Animal Health Limited
ANADA
200-489
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
No use class stated or implied
Composition / specifications
Each milliliter contains flunixin meglumine equivalent to 50 mg of flunixin.

Swine

Indication
For the control of pyrexia associated with swine respiratory disease.
Dosage
Administer 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight as a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.
Limitations
For intramuscular use in swine. Not tor use in breeding swine.

Flunine-S™

SPL · SPL

FDA Structured Product Label

Flunine-S™

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
200-791
Status
RX
Form
Injectable Solution
Route
Intramuscular
Composition / specifications
50 mg flunixin (equivalent to 83 mg flunixin meglumine) per mL

Swine

Indication

For the control of pyrexia associated with swine respiratory disease

Dosage

2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.

Banamine® Paste

SPL · SPL

FDA Structured Product Label

Banamine® Paste

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.
NADA
137-409
Status
RX
Form
Paste
Route
Oral
Species
Horse, Not For Meat Production
Composition / specifications
Each 30-gram syringe contains flunixin meglumine equivalent to 1,500 milligrams of flunixin.

Horses

Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders.
Dosage
0.5 milligram of flunixin per pound of body weight daily.
Limitations

For oral use only. Treatment should not exceed 5 consecutive days. The effect of this drug on pregnancy has not been determined. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunine™

SPL · SPL

FDA Structured Product Label

Flunine™

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
200-781
Status
RX
Form
Injectable Solution
Route
Intramuscular, Intravenous
Species
Dairy, excluding dry cows • No Use Class Stated Or Implied
Composition / specifications
50 mg/mL

Horses

Indication

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.

Dosage

The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Treatment may be repeated when signs of colic recur.

Cattle

Indication

For the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.

Dosage

The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia, is 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration.

Flunixin Injection - S

SPL · SPL

FDA Structured Product Label

Flunixin Injection - S

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
200-476
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
No use class stated or implied

Label highlights

Indication
For the control of pyrexia associated with swine respiratory disease.
Dosage
The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site
Limitations
Not for use in breeding swine. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flu-Nix™

SPL · SPL

FDA Structured Product Label

Flu-Nix™

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

Sponsor
Huvepharma EOOD
ANADA
200-061
Status
RX
Form
Liquid (Solution)
Route
Intramuscular, Intravenous
Species
Horse, Not For Meat Production • Beef And Dairy
Composition / specifications
Each mL contains flunixin meglumine equivalent to 50 mg flunixin.

Horses

Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders and alleviation of visceral pain associated with colic.
Dosage
0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Beef and dairy)

Indication
For control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.
Dosage
1.1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine®

SPL · SPL

FDA Structured Product Label

Banamine® Banamine®-S

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.
NADA
101-479
Status
RX
Form
Injectable Solution
Route
Intravenous, Intramuscular
Species
Horse, Not For Meat Production • Beef, excluding breeding bulls • Dairy, excluding dry dairy cows and breeding bulls • Calves, excluding veal calves
Composition / specifications
The drug contains 50 milligrams of flunixin per milliliter of aqueous solution.

Horses

Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.

Dosage

0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.

Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle

Indication

For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia.

Dosage

1. 1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days (control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia).

2. 2mg/kg (1.0 mg/lb) of body weight given once by intravenous administration for control of pyrexia associated with acute bovine mastitis.

Limitations

Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine®-S

SPL · SPL

FDA Structured Product Label

Banamine® Banamine®-S

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.
NADA
101-479
Status
RX
Form
Injectable Solution
Route
Intravenous, Intramuscular
Species
Horse, Not For Meat Production • Beef, excluding breeding bulls • Dairy, excluding dry dairy cows and breeding bulls • Calves, excluding veal calves
Composition / specifications
The drug contains 50 milligrams of flunixin per milliliter of aqueous solution.

Horses

Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.

Dosage

0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.

Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle

Indication

For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia.

Dosage

1. 1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days (control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia).

2. 2mg/kg (1.0 mg/lb) of body weight given once by intravenous administration for control of pyrexia associated with acute bovine mastitis.

Limitations

Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunazine®

SPL · SPL

FDA Structured Product Label

Flunazine®

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

Sponsor
Bimeda Animal Health Limited
ANADA
200-581
Status
RX
Form
Paste
Route
Oral
Species
No Use Class Stated Or Implied
Composition / specifications
30 grams of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin.

Label highlights

Indication
For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse
Dosage
0.5 mg per pound of body weight per day for up to 5 days
Limitations
For oral use in horses only. Treatment should not exceed 5 consecutive days. The effect of flunixin meglumine on pregnancy has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Flunazine™

SPL · SPL

FDA Structured Product Label

Flunazine™

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

Sponsor
Bimeda Animal Health Limited
ANADA
200-387
Status
RX
Form
Liquid (Solution)
Route
Intravenous, Intramuscular
Species
Beef And Dairy • No Use Class Stated Or Implied
Composition / specifications
<span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each mL of solution contains flunixin meglumine equivalent to 50 mg flunixin.</span>

Cattle

Indication
For the control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis.
Dosage
1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) body weight given by slow intravenous administration, either once a day as a single dose, or divided into two doses at 12-hour intervals for up to 3 days; for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia. 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration for acute bovine mastitis.
Limitations
The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in calves to be processed for veal. Do not use in dry dairy cows.

Horses

Indication
For the alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.
Dosage
0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Meglumine Solution

SPL · SPL

FDA Structured Product Label

Flunixin Meglumine 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.
ANADA
200-142
Status
RX
Form
Liquid (Solution)
Route
Intramuscular, Intravenous
Species
Horse, Not For Meat Production
Composition / specifications
The drug contains 50 milligrams of flunixin per milliliter of aqueous solution.

Horses

Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of pain associated with colic.
Dosage
0.5 mg per pound (/lb) of body weight per day, intravenously or intramuscularly, for up to 5 days.
Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Meglumine Injection

SPL · SPL

FDA Structured Product Label

Flunixin Meglumine 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
Elanco US Inc.
ANADA
200-124
Status
RX
Form
Liquid (Solution)
Route
Intravenous, Intramuscular
Species
Beef And Dairy • No Use Class Stated Or Implied
Composition / specifications
<pre><span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each mL of solution contains flunixin meglumine equivalent to 50 mg flunixin. </span></pre><p>&nbsp;

Horses

Indication
For the alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.
Dosage
0.5 mg per pound of body weight once daily, intravenously or intramuscularly, for up to 5 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle

Indication
For control of pyrexia associated with acute bovine mastitis.
Dosage
2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lb) of body weight given once by intravenous administration.
Limitations
Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Indication
For control of pyrexia associated with bovine respiratory disease and endotoxemia. Also indicated for the control of inflammation in endotoxemia.
Dosage
1.1 to 2.2 mg/kg (0.5 to 1.0 mg/lb; 1 to 2 mL per 100 lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.
Limitations
Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine® Granules

SPL · SPL

FDA Structured Product Label

Banamine® Granules

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.
NADA
106-616
Status
RX
Form
Top Dressing In Feed
Route
Oral
Species
Horse, Not For Meat Production
Composition / specifications
Each 10-gram packet contains flunixin meglumine equivalent to 250 milligrams of flunixin.

Horses

Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Dosage
0.5 milligram of flunixin per pound of body weight (one packet per 500 pounds) per day.
Limitations
Administer daily dose for up to 5 days by sprinkling on small amount of feed. The effect of this drug on pregnancy has not been determined. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Meglumine SPL

SPL · Structured Product Label

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

Flunixin Meglumine SPL

SPL · Structured Product Label

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

Flunixin Meglumine SPL

SPL · Structured Product Label

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

Flunixin Meglumine SPL

SPL · Structured Product Label

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

Banamine SPL

SPL · Structured Product Label

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

VETAMEG SPL

SPL · Structured Product Label

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

Flunazine-S SPL

SPL · Structured Product Label

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

Flunine SPL

SPL · Structured Product Label

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

Flunazine SPL

SPL · Structured Product Label

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

Prevail SPL

SPL · Structured Product Label

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

Flunixin-S SPL

SPL · Structured Product Label

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

Vetameg S SPL

SPL · Structured Product Label

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

VETAMEG SPL

SPL · Structured Product Label

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

Banamine SPL

SPL · Structured Product Label

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

VetaMeg SPL

SPL · Structured Product Label

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

Flunazine SPL

SPL · Structured Product Label

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

Flunixin SPL

SPL · Structured Product Label

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

Flunixin SPL

SPL · Structured Product Label

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

Flunixin SPL

SPL · Structured Product Label

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

Flunixin SPL

SPL · Structured Product Label

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

Banamine SPL

SPL · Structured Product Label

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

Flu-Nix SPL

SPL · Structured Product Label

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

Prevail SPL

SPL · Structured Product Label

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

VetaMeg SPL

SPL · Structured Product Label

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

Flunixin Meglumine SPL

SPL · Structured Product Label

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

Flunixin Meglumine SPL

SPL · Structured Product Label

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

Flunixin Meglumine SPL

SPL · Structured Product Label

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

Flunixin Meglumine SPL

SPL · Structured Product Label

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

UCM210561.pdf

FOI · FOI

FOI Summary oA 200-791 Approved April 3 2025_ceg_ef.pdf

FOI · FOI

FOI Summary oA 200-781 Approved May 16, 2024.pdf

FOI · FOI

UCM181537.pdf

FOI · FOI

UCM241575.pdf

FOI · FOI

ucm061576.pdf

FOI · FOI

A200061_Orig_09_11_1996.pdf

FOI · FOI

ucm064912.pdf

FOI · FOI

ucm064910.pdf

FOI · FOI

ucm064907.pdf

FOI · FOI

353.pdf

FOI · FOI

UCM421903.pdf

FOI · FOI

A200387_Supp_12_18_2008.pdf

FOI · FOI

ucm061339.pdf

FOI · FOI

A200142_Orig_09_25_1995.pdf

FOI · FOI

ucm061593.pdf

FOI · FOI

ucm061738.pdf

FOI · FOI

ucm061590.pdf

FOI · FOI

A200124_Org_9_25_1995.pdf

FOI · FOI

FOI Summary oA 200-828 Approved January 9, 2026.pdf

FOI · FOI summary

UCM203309.pdf

FOI · FOI summary

UCM231147.pdf

FOI · FOI summary

UCM243040.pdf

FOI · FOI summary

Veterinary reference (advanced)

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

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Banamine Flu-Nix Flunazine Flunazine-S Flunine Flunixin Flunixin Meglumine Flunixin-S Prevail VETAMEG VetaMeg Vetameg S
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both FDA-labeled species: Beef, Beef And Dairy, Calves, Dairy, Horse, No Use Class Stated Or Implied, No use class stated or implied
Rx/OTC: RX
Form/route: Injectable Solution, Liquid (Solution), Paste, Top Dressing In Feed Intramuscular, Intravenous, Oral
Applications: ANADA 200-489 • ANADA 200-791 • NADA 137-409 • ANADA 200-781 • ANADA 200-476 • ANADA 200-061 • NADA 101-479 • ANADA 200-581 • ANADA 200-387 • ANADA 200-142 • ANADA 200-124 • NADA 106-616
NDC: Packages 0061-0214-02 0061-0851-03 0061-0851-04 0061-4363-01 0061-4363-02 0061-4363-03 Products 0061 11695 13985 23243 46066 49452
Documents: 25 (FOI: 19) • SPL: 13 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
Related conditions: Mastitis Pain (acute, chronic)
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
  • Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Tiredness (lethargy) (1) Surgical site disorder (1) Shaking (1) Reluctant to move (1) Proprioception deficit (1) Polydipsia (1) Peritonitis (1) Panting (1)

Identifiers & Packages

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

Identifiers
ANADA: 200061 ANADA: 200124 ANADA: 200142 ANADA: 200387 ANADA: 200476 ANADA: 200489 ANADA: 200581 ANADA: 200781 ANADA: 200791 ANADA: 200828 NADA: 101479 NADA: 106616 NADA: 137409 NADA: 141299 NADA: 141312 NDC Package: 0061-0214-02 NDC Package: 0061-0851-03 NDC Package: 0061-0851-04 NDC Package: 0061-4305-01 NDC Package: 0061-4305-02 NDC Package: 0061-4305-03 NDC Package: 0061-4363-01 NDC Package: 0061-4363-02 NDC Package: 0061-4363-03
Package NDC Product NDC Form / Route Status
0061-0214-02 0061 -
0061-0851-03 0061 -
0061-0851-04 0061 -
0061-4305-01 0061 -
0061-4305-02 0061 -
0061-4305-03 0061 -
0061-4363-01 0061 -
0061-4363-02 0061 -
0061-4363-03 0061 -
11695-7021-1 11695 -
11695-7021-2 11695 -
13985-018-02 13985 -
13985-018-04 13985 -
13985-707-15 13985 -
23243-0120-4 23243 -
23243-0120-5 23243 -
46066-008-02 46066 -
46066-008-04 46066 -
46066-102-03 46066 -
46066-102-04 46066 -

Enriched Documents

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

  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Banamine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • VETAMEG SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunazine-S SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunazine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Prevail SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin-S SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Vetameg S SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • VETAMEG SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Banamine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • VetaMeg SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunazine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Banamine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flu-Nix SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Prevail SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • VetaMeg SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Flunixin Meglumine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FOI Summary oA 200-828 Approved January 9, 2026.pdf • FOI summary • Official • Feb. 3, 2026
    FDA FOI summary for application 200828
  • A-200489-C-0073-NL-AA_PI_2.pdf • Official label • Official • Dec. 16, 2025
    FDA official labeling for application 200489
  • UCM210561.pdf • FOI summary • Official • Dec. 16, 2025
    FDA FOI summary for application 200489
  • FOI Summary oA 200-791 Approved April 3 2025_ceg_ef.pdf • FOI summary • Official • June 3, 2025
    FDA FOI summary for application 200791
  • N-137409-C-0125-NL-AA_PI.pdf • Official label • Official • Feb. 24, 2025
    FDA official labeling for application 137409
  • UCM203309.pdf • FOI summary • Official • Aug. 6, 2024
    FDA FOI summary for application 141299
  • UCM231147.pdf • FOI summary • Official • Aug. 6, 2024
    FDA FOI summary for application 141299
  • A-200781-C-0017-NL-AA_PI.pdf • Official label • Official • July 16, 2024
    FDA official labeling for application 200781
  • FOI Summary oA 200-781 Approved May 16, 2024.pdf • FOI summary • Official • July 16, 2024
    FDA FOI summary for application 200781
  • A-200476-R-0049-CS-AA_PI.pdf • Official label • Official • Aug. 21, 2023
    FDA official labeling for application 200476
  • UCM181537.pdf • FOI summary • Official • Aug. 21, 2023
    FDA FOI summary for application 200476
  • A200061_Orig_09_11_1996.pdf • FOI summary • Official • June 1, 2022
    FDA FOI summary for application 200061

Data Sources & Change Log

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

Official 103 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-05-05)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-05-03)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-04-30)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-04-29)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-04-28)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-04-27)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-04-26)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-04-25)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-04-11)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-05-05)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-05-03)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-04-30)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-04-29)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-04-28)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-04-27)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-04-26)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-04-25)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-04-11)
  • contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-02-12)
  • indications: For the control of pyrexia associated with swine respiratory disease For the control of pyrexia associated with swine respiratory disease. Horse: For the allev… (Official, 2026-05-05)
Recent Revisions
  • side_effects updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-26 10:06 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
Flunazine®-S
RX
Flunixin Meglumine
Injectable Solution Intramuscular
Bimeda Animal Health Limited ANADA 200-489 Approved Dec 16, 2025
Flunine-S™
RX
Flunixin Meglumine
Injectable Solution Intramuscular
Cronus Pharma Specialities India Private Ltd. ANADA 200-791 Approved Jun 3, 2025
Banamine® Paste
RX
Flunixin Meglumine
Paste Oral
Intervet, Inc. NADA 137-409 Approved Feb 24, 2025
Flunine™
RX
Flunixin Meglumine
Injectable Solution Intramuscular, Intravenous
Cronus Pharma Specialities India Private Ltd. ANADA 200-781 Approved Jul 16, 2024
Flunixin Injection - S
RX
Flunixin Meglumine
Liquid (Solution) Intramuscular
Norbrook Laboratories, Ltd. ANADA 200-476 Approved Aug 21, 2023
Flu-Nix™
RX
Flunixin Meglumine
Liquid (Solution) Intramuscular, Intravenous
Huvepharma EOOD ANADA 200-061 Approved Jun 1, 2022
Banamine® Banamine®-S
RX
Flunixin Meglumine
Injectable Solution Intravenous, Intramuscular
Intervet, Inc. NADA 101-479 Approved May 3, 2022
Flunazine®
RX
Flunixin Meglumine
Paste Oral
Bimeda Animal Health Limited ANADA 200-581 Approved Oct 2, 2018
Flunazine™
RX
Flunixin Meglumine
Liquid (Solution) Intravenous, Intramuscular
Bimeda Animal Health Limited ANADA 200-387 Approved Oct 2, 2018
Flunixin Meglumine Solution
RX
Flunixin Meglumine
Liquid (Solution) Intramuscular, Intravenous
Zoetis Inc. ANADA 200-142 Approved Jul 28, 2017
Flunixin Meglumine Injection
RX
Flunixin Meglumine
Liquid (Solution) Intravenous, Intramuscular
Elanco US Inc. ANADA 200-124 Approved May 16, 2017
Banamine® Granules
RX
Flunixin Meglumine
Top Dressing In Feed Oral
Intervet, Inc. NADA 106-616 Approved Jun 1, 2016

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

What It's For (FDA Label Highlights)

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

Species: No use class stated or implied
Composition / specifications
Each milliliter contains flunixin meglumine equivalent to 50 mg of flunixin.
Swine
Indication
For the control of pyrexia associated with swine respiratory disease.
Dosage
Administer 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight as a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.
Limitations
For intramuscular use in swine. Not tor use in breeding swine.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
50 mg flunixin (equivalent to 83 mg flunixin meglumine) per mL
Swine
Indication

For the control of pyrexia associated with swine respiratory disease

Dosage

2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Each 30-gram syringe contains flunixin meglumine equivalent to 1,500 milligrams of flunixin.
Horses
Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders.
Dosage
0.5 milligram of flunixin per pound of body weight daily.
Limitations

For oral use only. Treatment should not exceed 5 consecutive days. The effect of this drug on pregnancy has not been determined. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dairy, excluding dry cows • No Use Class Stated Or Implied
Composition / specifications
50 mg/mL
Horses
Indication

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.

Dosage

The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Treatment may be repeated when signs of colic recur.

Limitations
Cattle
Indication

For the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.

Dosage

The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia, is 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied
Label highlights
Indication
For the control of pyrexia associated with swine respiratory disease.
Dosage
The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site
Limitations
Not for use in breeding swine. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production • Beef And Dairy
Composition / specifications
Each mL contains flunixin meglumine equivalent to 50 mg flunixin.
Horses
Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders and alleviation of visceral pain associated with colic.
Dosage
0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cattle (Beef and dairy)
Indication
For control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.
Dosage
1.1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production • Beef, excluding breeding bulls • Dairy, excluding dry dairy cows and breeding bulls • Calves, excluding veal calves
Composition / specifications
The drug contains 50 milligrams of flunixin per milliliter of aqueous solution.
Horses
Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.

Dosage

0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.

Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cattle
Indication

For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia.

Dosage

1. 1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days (control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia).

2. 2mg/kg (1.0 mg/lb) of body weight given once by intravenous administration for control of pyrexia associated with acute bovine mastitis.

Limitations

Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
30 grams of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin.
Label highlights
Indication
For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse
Dosage
0.5 mg per pound of body weight per day for up to 5 days
Limitations
For oral use in horses only. Treatment should not exceed 5 consecutive days. The effect of flunixin meglumine on pregnancy has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Dairy • No Use Class Stated Or Implied
Composition / specifications
<span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each mL of solution contains flunixin meglumine equivalent to 50 mg flunixin.</span>
Cattle
Indication
For the control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis.
Dosage
1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) body weight given by slow intravenous administration, either once a day as a single dose, or divided into two doses at 12-hour intervals for up to 3 days; for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia. 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration for acute bovine mastitis.
Limitations
The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in calves to be processed for veal. Do not use in dry dairy cows.
Horses
Indication
For the alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.
Dosage
0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
The drug contains 50 milligrams of flunixin per milliliter of aqueous solution.
Horses
Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of pain associated with colic.
Dosage
0.5 mg per pound (/lb) of body weight per day, intravenously or intramuscularly, for up to 5 days.
Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Dairy • No Use Class Stated Or Implied
Composition / specifications
<pre><span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each mL of solution contains flunixin meglumine equivalent to 50 mg flunixin. </span></pre><p>&nbsp;
Horses
Indication
For the alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.
Dosage
0.5 mg per pound of body weight once daily, intravenously or intramuscularly, for up to 5 days.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cattle
Indication
For control of pyrexia associated with acute bovine mastitis.
Dosage
2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lb) of body weight given once by intravenous administration.
Limitations
Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Indication
For control of pyrexia associated with bovine respiratory disease and endotoxemia. Also indicated for the control of inflammation in endotoxemia.
Dosage
1.1 to 2.2 mg/kg (0.5 to 1.0 mg/lb; 1 to 2 mL per 100 lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.
Limitations
Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Each 10-gram packet contains flunixin meglumine equivalent to 250 milligrams of flunixin.
Horses
Indication
For alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Dosage
0.5 milligram of flunixin per pound of body weight (one packet per 500 pounds) per day.
Limitations
Administer daily dose for up to 5 days by sprinkling on small amount of feed. The effect of this drug on pregnancy has not been determined. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia. For the control of pyrexia associated with swine respiratory disease.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by 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).

Digestive
Loss of appetite (1) • Cat Haemorrhagic diarrhoea (1) • Dog Diarrhea (1) • Dog Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Tiredness (1) • Cat

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (ectoparasite) - tick NOS (1) • Cat

Showing top 5 for Effectiveness.

Other
Surgical site disorder (1) • Dog Shaking (1) • Dog Reluctant to move (1) • Cat Proprioception deficit (1) • Dog Polydipsia (1) • Dog
Show more (20)
Peritonitis (1) • Dog Panting (1) • Dog Other abnormal test result NOS (1) • Dog Not eating (1) • Dog Leucopenia NOS (1) • Cat Intestinal perforation (1) • Dog Hypothermia (1) • Dog Febrile (1) • Cat Elevated total bilirubin (1) • Dog Elevated liver enzymes (1) • Dog Elevated alanine aminotransferase (1) • Dog Ear infection NOS (1) • Dog Distension of abdomen (1) • Dog Dehydration (1) • Dog Decreased red blood cell count (1) • Dog Death (1) • Dog Claw / hoof / nail disorder NOS (1) • Dog Anaphylaxis (1) • Dog Adipsia (1) • Cat Abnormal radiograph finding (1) • Dog

Showing top 5 for Other.

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

Adverse Event Case Summaries (openFDA)

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

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.