Meds A-Z
Flunixin Meglumine
Detailed information about Flunixin Meglumine
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of BRD-associated pyrexia in beef and non-lactatin...
What it does:
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...
When it's needed:
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 h...
Call your vet sooner if you notice:
- 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.
Commonly reported reactions:
- (2 reports)
- (1 reports)
- (1 reports)
What to 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?
Flunixin Meglumine
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Intervet, Inc.
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200828 · 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
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.
- 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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 2 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (25) Cat (7)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2019-US-025839
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 45 • Secondary summaries: 0
- FOI Summary oA 200-828 Approved January 9, 2026.pdf · FOI
- nixiFLOR™ · SPL
- UCM210561.pdf · FOI
- A-200489-C-0073-NL-AA_PI_2.pdf · Labeling
- Flunazine®-S · SPL
- FOI Summary oA 200-791 Approved April 3 2025_ceg_ef.pdf · FOI
- Flunine-S™ · SPL
- N-137409-C-0125-NL-AA_PI.pdf · Labeling
- Banamine® Paste · SPL
- UCM231147.pdf · FOI
- UCM203309.pdf · FOI
- Resflor GOLD® · SPL
- FOI Summary oA 200-781 Approved May 16, 2024.pdf · FOI
- A-200781-C-0017-NL-AA_PI.pdf · Labeling
- Flunine™ · SPL
- UCM181537.pdf · FOI
- A-200476-R-0049-CS-AA_PI.pdf · Labeling
- Flunixin Injection - S · SPL
- UCM241575.pdf · FOI
- ucm061576.pdf · FOI
- A200061_Orig_09_11_1996.pdf · FOI
- Flu-Nix™ · SPL
- ucm064912.pdf · FOI
- ucm064910.pdf · FOI
- ucm064907.pdf · FOI
- 353.pdf · FOI
- 101-479 · EA
- 101-479 · FONSI
- Banamine® · SPL
- Banamine®-S · SPL
- UCM243040.pdf · FOI
- Hexasol® Injection · SPL
- UCM421903.pdf · FOI
- Flunazine® · SPL
- A200387_Supp_12_18_2008.pdf · FOI
- ucm061339.pdf · FOI
- Flunazine™ · SPL
- A200142_Orig_09_25_1995.pdf · FOI
- Flunixin Meglumine Solution · SPL
- ucm061593.pdf · FOI
- ucm061738.pdf · FOI
- ucm061590.pdf · FOI
- A200124_Org_9_25_1995.pdf · FOI
- Flunixin Meglumine Injection · SPL
- Banamine® Granules · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17866 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18227/nixiFLOR%E2%84%A2 · 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
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2484/Banamine%C2%AE%20Paste · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/864 · document · FOI
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:15 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
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.
- 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)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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.
-
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
-
ucm061576.pdf
• FOI summary • Official
• June 1, 2022
FDA FOI summary for application 200061
-
UCM241575.pdf
• FOI summary • Official
• June 1, 2022
FDA FOI summary for application 200061
-
353.pdf
• FOI summary • Official
• May 3, 2022
FDA FOI summary for application 101479
-
ucm064907.pdf
• FOI summary • Official
• May 3, 2022
FDA FOI summary for application 101479
-
ucm064910.pdf
• FOI summary • Official
• May 3, 2022
FDA FOI summary for application 101479
-
ucm064912.pdf
• FOI summary • Official
• May 3, 2022
FDA FOI summary for application 101479
-
UCM243040.pdf
• FOI summary • Official
• March 4, 2022
FDA FOI summary for application 141312
-
UCM421903.pdf
• FOI summary • Official
• Oct. 2, 2018
FDA FOI summary for application 200581
-
ucm061339.pdf
• FOI summary • Official
• Oct. 2, 2018
FDA FOI summary for application 200387
-
A200387_Supp_12_18_2008.pdf
• FOI summary • Official
• Oct. 2, 2018
FDA FOI summary for application 200387
-
A200142_Orig_09_25_1995.pdf
• FOI summary • Official
• July 28, 2017
FDA FOI summary for application 200142
-
A200124_Org_9_25_1995.pdf
• FOI summary • Official
• May 16, 2017
FDA FOI summary for application 200124
-
ucm061590.pdf
• FOI summary • Official
• May 16, 2017
FDA FOI summary for application 200124
-
ucm061738.pdf
• FOI summary • Official
• May 16, 2017
FDA FOI summary for application 200124
-
ucm061593.pdf
• FOI summary • Official
• May 16, 2017
FDA FOI summary for application 200124
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- 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)
- side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Official, 2026-02-12)
- usage: For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. For control of pyre… (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
FDA Products & Applications (Animal Drugs @ FDA)
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
nixiFLOR™
RX
Florfenicol Flunixin Meglumine
Injectable Solution
• Subcutaneous
|
Parnell Technologies Pty. Ltd. | ANADA 200-828 | Approved | Feb 3, 2026 |
|
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 |
|
Resflor GOLD®
RX
Florfenicol Flunixin Meglumine
Injectable Solution
• Subcutaneous
|
Intervet, Inc. | NADA 141-299 | Approved | Aug 6, 2024 |
|
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 |
|
Hexasol® Injection
RX
Flunixin Meglumine Oxytetracycline
Liquid (Solution)
• Intramuscular, Subcutaneous
|
Norbrook Laboratories, Ltd. | NADA 141-312 | Approved | Mar 4, 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.
Composition / specifications
For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.
40 mg florfenicol/kg body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/100 lbs) once, by subcutaneous injection.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the control of pyrexia associated with swine respiratory disease
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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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
Composition / specifications
Administer once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb).
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
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.
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.
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.
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.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.
0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.
For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia.
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.
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
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.
- nixiFLOR™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM210561.pdf
Summary
For the control of pyrexia associated with swine respiratory disease. -
Labeling A-200489-C-0073-NL-AA_PI_2.pdf
- Flunazine®-S (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the control of pyrexia associated with swine respiratory disease
- Flunine-S™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Labeling N-137409-C-0125-NL-AA_PI.pdf
- Banamine® Paste (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM231147.pdf
Summary
This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the treatment of BRD and control of BRD-associated pyrexia indication. -
FOI UCM203309.pdf
Summary
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.
- Resflor GOLD® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
Horse: 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.
Cattle: 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. -
Labeling A-200781-C-0017-NL-AA_PI.pdf
- Flunine™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM181537.pdf
Summary
For the control of pyrexia associated with swine respiratory disease. -
Labeling A-200476-R-0049-CS-AA_PI.pdf
- Flunixin Injection - S (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM241575.pdf
Summary
This supplement provides for a change in proprietary name and the addition of the lactating dairy cattle indication, “For the control of pyrexia associated with acute bovine mastitis.”
-
FOI ucm061576.pdf
Summary
This supplement provides for the addition of a claim for intravenous use in beef cattle and nonlactating dairy cattle to the labeling of the approved product Flunixin Meglumine Solution. The exclusivity period protecting this claim for the pioneer product expired on May 6, 2001. -
Summary
For the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
- Flu-Nix™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm064912.pdf
Summary
This supplement allows for use in swine for the control of pyrexia associated with swine respiratory disease. This product has been approved for beef and lactating dairy cattle and horses. -
FOI ucm064910.pdf
Summary
This supplement allows for use in lactating dairy cattle for the existing indications of “the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia.” Additionally, it allows for a new indication “for the control of pyrexia associated with acute bovine mastitis” and it establishes a tolerance for residues of flunixin in milk. -
FOI ucm064907.pdf
Summary
This supplement provides for an additional statement added to the Precaution section of the labeling and a heading change on the label from Warning to Adverse Reactions to the previously approved product labeling for BANAMINE® Injectable Solution. -
FOI 353.pdf
Summary
This supplement provides for the additional species, cattle, to be added to the previously approved product, BANAMINE® Injectable Solution.
-
EA 101-479
-
FONSI 101-479
- Banamine® (ZIP)
- Banamine®-S (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM243040.pdf
Summary
For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and non-lactating dairy cattle.
- Hexasol® Injection (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM421903.pdf
Summary
For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
- Flunazine® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
The supplement requests the addition of a new indication, "for the control of pyrexia associated with acute bovine mastitis", that is no longer protected by marketing exclusivity.
-
FOI ucm061339.pdf
Summary
Horse: recommended 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.
Cattle: indicated for the control of pyrexia associated with bovine respiratory disease and endotoxemia. Flunixin Meglumine Injection is also indicated for the control of inflammation in endotoxemia.
- Flunazine™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm061593.pdf
Summary
The effect of this supplement is to allow for the addition of a new indication, “for the control of pyrexia associated with acute bovine mastitis”, that is no longer protected by marketing exclusivity. -
FOI ucm061738.pdf
Summary
This supplement provides the addition of lactating dairy cattle to the existing claim allowing for the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia. The addition of lactating dairy cattle to the pioneer labeling was approved on August 19, 2004, and was not protected by exclusivity. -
FOI ucm061590.pdf
Summary
The supplement provides revised labeling with the addition of a new species, cattle, to the previously approved generic product for horses only. -
Summary
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.
FDA page: Open in Animal Drugs @ FDA
- Banamine® Granules (ZIP)
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.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 8 and Cat 8 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Adverse Event Case Summaries (openFDA)
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Griffon - French Wire-haired Pointing, Female, 23 month, 15.4 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy - NOS, Other abnormal test result NOS, Elevated total bilirubin, Decreased red blood cell count, Ear infection NOS… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2023-US-062807
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 23.00 Month
- Weight: 15.400 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, ['Retriever - Labrador', 'Dog (unknown)'], Female, 3 year, 18.824 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Vomiting, Weakness, Diarrhea, Haemorrhagic diarrhoea, Anaphylaxis… • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2023-US-009609
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 3.00 Year
- Weight: 18.824 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Injection, solution
Cat, Siamese, Male, 7 year, 6.804 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Tiredness (lethargy), Third eyelid protrusion, Loss of appetite, Adipsia, Lack of efficacy (ectoparasite) - tick NOS… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2020-US-020224
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 7.00 Year
- Weight: 6.804 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Dog, Ridgeback - Rhodesian, Male, 6 year, 32.749 kilogram • Drug: MSK, Liquid, Unknown • Reactions: Shaking, Panting, Tiredness (lethargy), Proprioception deficit, Dehydration… • Outcome: Died
- Report ID: USA-USFDACVM-2019-US-026054
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 6.00 Year
- Weight: 32.749 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Liquid
Dog, Retriever - Labrador, Female, 2 year, 34.927 kilogram • Drug: MSK, Intramuscular, Dose: 0.70 mL per unknown, Frequency: 5 per month • Reactions: Not eating, Tiredness (lethargy), Vomiting, Surgical site disorder, Distension of abdomen… • Outcome: Died
- Report ID: USA-USFDACVM-2019-US-025839
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 2.00 Year
- Weight: 34.927 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Intramuscular
- Dose: 0.70 mL per unknown
- Frequency: 5 per month
Dog, Spaniel - Springer English, Male, 2 year • Drug: MSK, Intravenous, Dose: 4 Milligram per unknown • Reactions: Lack of efficacy - NOS, Claw / hoof / nail disorder NOS • Outcome: Ongoing
- Report ID: USA-USFDACVM-2018-US-021211
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 2.00 Year
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Intravenous
- Dose: 4 Milligram per unknown
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.