Roxee Medication Guide

Flunixin Meglumine

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 Injectable Solution Multiple FDA labelers Official label facts Owner quick guide first

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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. Do not start, stop, or change treatment without your veterinarian.

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Reference facts

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FDA applications

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Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:45 AM UTC
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Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
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Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).

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Flunixin Meglumine

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

Both Injectable 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.

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® Banamine®-S, Banamine® Paste, Flu-Nix™, Flunixin Meglumine Injection

Manufacturer

Multiple FDA labelers

Species

Both, Horse, Beef, Dairy

Dosage forms

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

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

Banamine® Banamine®-S Banamine® Paste Flu-Nix™ Flunixin Meglumine Injection Flunixin Meglumine Solution Flunixin Injection Flunazine™ Flunixin Injection - S Flunazine®-S Flunazine® Flunine™ Flunine-S™ Banamine® Granules Flunixin Meglumine Flunazine-S VETAMEG Vetameg S Banamine Flunixin-S Prevail Flunazine Flunine Flunixin Flu-Nix

Dosage forms

Injectable Solution Paste Liquid (Solution) Top Dressing In Feed

Indications / Uses

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, Dairy, excluding dry cows

Yes. Roxee shows this as prescription-only.

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

Related Conditions

Mastitis Pain (acute, chronic)

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://www.accessdata.fda.gov/spl/data/aa37e4de-dec2-4900-96f5-b51d2b404731/aa37e4de-dec2-4900-96f5-b51d2b404731.xml
Last refreshed: Jun 22, 2026, 10:45 a.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

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

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?

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 Flunixin Meglumine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2019-US-025839

Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 26 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2019-US-025839

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-2019-US-025839

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

Tiredness (lethargy) (1 reports), Surgical site disorder (1 reports), Shaking (1 reports), Reluctant to move (1 reports), Proprioception deficit (1 reports)

Body systems represented Signal grouping

Digestive (4), Neurologic (1), Effectiveness (2), Other (25)

Species and breed lens

Species represented in reports Species lens

Dog (25 reports), Cat (7 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Flunixin Meglumine 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

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

Call sooner if Escalation

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

Bottom line: Use this Flunixin Meglumine 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

openFDA case USA-USFDACVM-2019-US-025839 · adverse_reaction · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
FOI · document · documents
Labeling · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Flunine-S™ · official_label
openFDA case USA-USFDACVM-2019-US-025839 · adverse_reaction

Safety & side effects

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.

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 Dairy, Calves, Dairy, Horse

Indication / use

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

Form / route / dose

Form: Injectable Solution, Liquid (Solution), Paste, Top Dressing In Feed
Route: Intramuscular, Intravenous, Oral
Confirm product label and patient-specific plan.

Warnings

High: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veteri…

Adverse-event caveat

No stored openFDA case explorer rows are linked yet.

Source docs

A-200308-R-0099-CS-AA_PI.pdf Official label / PI
A-200489-C-0073-NL-AA_PI_2.pdf Official label / PI
N-137409-C-0125-NL-AA_PI.pdf Official label / PI

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: 200308 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

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200308 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200489 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

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:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

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

Reported cases

Serious reports

Species represented

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

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

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:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2019-US-025839

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.

A-200308-R-0099-CS-AA_PI.pdf Official label / PI · Labeling 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

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

Owner handouts

No owner handouts linked yet.

Official label / PI

SPL

Open original

FDA Structured Product Label

Flunixin 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: Norbrook Laboratories, Ltd.
ANADA: 200-308
Status: RX
Form: Injectable Solution
Route: Intravenous, Intramuscular
Species: Beef And Dairy

Composition / specifications

Each milliliter of solution contains flunixin meglumine equivalent to 50 mg flunixin.

Horses

Indication

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

Dosage

0.5 mg per pound (1mL/100lbs) 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 bovine respiratory disease, acute bovine mastitis, 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 lbs) 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

Flunazine®-S

SPL · SPL

Open original

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 Ltd.
ANADA: 200-489
Status: RX
Form: Injectable Solution
Route: Intramuscular

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

Open original

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

Open original

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

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

Open original

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

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

Open original

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

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

Open original

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 • 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

Open original

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 • Beef • Dairy • 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

Open original

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 • Beef • Dairy • 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

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

Flunazine®

SPL · SPL

Open original

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 Ltd.
ANADA: 200-581
Status: RX
Form: Paste
Route: Oral

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

Open original

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 Ltd.
ANADA: 200-387
Status: RX
Form: Liquid (Solution)
Route: Intravenous, Intramuscular
Species: Beef And Dairy

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

Open original

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

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

Open original

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

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> 

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

Open original

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

Composition / specifications

Each 10-gram packet contains flunixin meglumine equivalent to 250 milligrams of flunixin.

Horses

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1059 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1058 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/822 · document · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1360/Flunixin%20Injection · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1195 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/2340 · document · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2041/Flunazine%C2%AE-S · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16765 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17066/Flunine-S%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/1998 · document · Labeling

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 22, 2026, 10:45 AM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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 22, 2026, 10:41 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

Rx/OTC: RX

Form/route: Injectable Solution, Liquid (Solution), Paste, Top Dressing In Feed • Intramuscular, Intravenous, Oral

Applications: ANADA 200-308 • 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: 28 (FOI: 21) • SPL: 14 • 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

Package NDC	Product NDC	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.
Flunixin Meglumine SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
A-200308-R-0099-CS-AA_PI.pdf • Official label • Official • May 14, 2026
FDA official labeling for application 200308
ucm061761.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 200308
ucm061762.pdf • FOI summary • Official • May 14, 2026
FDA FOI summary for application 200308
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

Data Sources & Change Log

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

Official 119 Clinical 60 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, 2026-06-22)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-22)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-21)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-20)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-13)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-12)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-12)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-11)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-11)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-10)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-08)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-07)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-06)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-05)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-04)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-03)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-02)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-01)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-06-01)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Clinical, 2026-05-31)

Recent Revisions

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
usage updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-12 10:04 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
Flunixin Injection RX Flunixin Meglumine Injectable Solution • Intravenous, Intramuscular Label highlights Official documents	Norbrook Laboratories, Ltd.	ANADA 200-308	Approved	May 14, 2026
Flunazine®-S RX Flunixin Meglumine Injectable Solution • Intramuscular Label highlights Official documents	Bimeda Animal Health Ltd.	ANADA 200-489	Approved	Dec 16, 2025
Flunine-S™ RX Flunixin Meglumine Injectable Solution • Intramuscular Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-791	Approved	Jun 3, 2025
Banamine® Paste RX Flunixin Meglumine Paste • Oral Label highlights Official documents	Intervet, Inc.	NADA 137-409	Approved	Feb 24, 2025
Flunine™ RX Flunixin Meglumine Injectable Solution • Intramuscular, Intravenous Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-781	Approved	Jul 16, 2024
Flunixin Injection - S RX Flunixin Meglumine Liquid (Solution) • Intramuscular Label highlights Official documents	Norbrook Laboratories, Ltd.	ANADA 200-476	Approved	Aug 21, 2023
Flu-Nix™ RX Flunixin Meglumine Liquid (Solution) • Intramuscular, Intravenous Label highlights Official documents	Huvepharma EOOD	ANADA 200-061	Approved	Jun 1, 2022
Banamine® Banamine®-S RX Flunixin Meglumine Injectable Solution • Intravenous, Intramuscular Label highlights Official documents	Intervet, Inc.	NADA 101-479	Approved	May 3, 2022
Flunazine® RX Flunixin Meglumine Paste • Oral Label highlights Official documents	Bimeda Animal Health Ltd.	ANADA 200-581	Approved	Oct 2, 2018
Flunazine™ RX Flunixin Meglumine Liquid (Solution) • Intravenous, Intramuscular Label highlights Official documents	Bimeda Animal Health Ltd.	ANADA 200-387	Approved	Oct 2, 2018
Flunixin Meglumine Solution RX Flunixin Meglumine Liquid (Solution) • Intramuscular, Intravenous Label highlights Official documents	Zoetis Inc.	ANADA 200-142	Approved	Jul 28, 2017
Flunixin Meglumine Injection RX Flunixin Meglumine Liquid (Solution) • Intravenous, Intramuscular Label highlights Official documents	Elanco US Inc.	ANADA 200-124	Approved	May 16, 2017
Banamine® Granules RX Flunixin Meglumine Top Dressing In Feed • Oral Label highlights Official documents	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: Beef And Dairy

Composition / specifications

Each milliliter of solution contains flunixin meglumine equivalent to 50 mg flunixin.

Horses

Indication

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

Dosage

0.5 mg per pound (1mL/100lbs) 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 bovine respiratory disease, acute bovine mastitis, 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 lbs) 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

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

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

FDA page: Open in Animal Drugs @ FDA

Species: Dairy

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

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

Limitations

FDA page: Open in Animal Drugs @ FDA

Label highlights

Indication

For the control of pyrexia associated with swine respiratory disease.

Dosage

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 • 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 • Beef • Dairy • 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

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

FDA page: Open in Animal Drugs @ FDA

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

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Dairy

Composition / specifications

Cattle

Indication

For the control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis.

Dosage

Limitations

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

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

Composition / specifications

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

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

FDA page: Open in Animal Drugs @ FDA

Usage

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

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.

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This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Flunixin Meglumine

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Flunixin Meglumine

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Flunixin Meglumine

Indications / Uses

Warnings / Contraindications

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What species is this commonly shown for?

Does this usually require a prescription?

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Source Documents

Owner handouts

Official label / PI

SPL

FOI

A-200308-R-0099-CS-AA_PI.pdf

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

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

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

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

101-479

101-479

Flunixin Injection

Flunixin Injection

Horses

Cattle

Flunazine®-S

Flunazine®-S

Swine

Flunine-S™

Flunine-S™

Swine

Banamine® Paste

Banamine® Paste

Horses

Flunine™

Flunine™

Horses

Cattle

Flunixin Injection - S

Flunixin Injection - S

Label highlights

Flu-Nix™

Flu-Nix™

Horses

Cattle (Beef and dairy)

Banamine®

Banamine® Banamine®-S

Horses

Cattle

Banamine®-S

Banamine® Banamine®-S

Horses

Cattle

Flunazine®

Flunazine®

Label highlights

Flunazine™

Flunazine™