Banamine

Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2025-04-30
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:44:35

Label at a glance#

ProductBanamine
Active ingredientFLUNIXIN MEGLUMINE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Paste –1500 mg
flunixin/syringe
Veterinary

For Oral Use in Horses Only

PRODUCT
INFORMATION

WARNINGS SECTION

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

DESCRIPTION SECTION

DESCRIPTION Each 30-g syringe of BANAMINE Paste contains flunixin meglumine equivalent to 1500 mg flunixin.

VETERINARY INDICATIONS SECTION

INDICATIONS BANAMINE Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

SPL UNCLASSIFIED SECTION

ACTIVITY Flunixin meglumine is a potent, nonnarcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS There are no known contraindications to this drug when used as directed.

FOOD SAFETY WARNING SECTION

WARNING Do not use in horses intended for human consumption.

PRECAUTIONS SECTION

PRECAUTIONS The effect of BANAMINE Paste on pregnancy has not been determined. Studies to date show there is no detrimental effect on stallion spermatogenesis with or following the recommended dose of BANAMINE Paste.

SPL UNCLASSIFIED SECTION

SIDE EFFECTS During field studies with BANAMINE Paste, no significant side effects were reported.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION The recommended dose of flunixin is 0.5 mg per lb of body weight once daily. The BANAMINE Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.

DOSAGE TABLE
Syringe Mark* Horse Weight (lbs)BANAMINE Paste Delivered (g)Mg Flunixin Delivered
0———
2502502.5125
5005005.0250
7507507.5375
1000100010.0500

* Use dial edge nearest syringe barrel to mark dose.

The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger.

Treatment may be given initially by intravenous or intramuscular injection of BANAMINE Solution, followed by BANAMINE Granules or BANAMINE Paste on Days 2 to 5. BANAMINE treatment should not exceed 5 consecutive days.

SPL UNCLASSIFIED SECTION

TOXICITY No toxic effects were observed in rats given oral flunixin 2 mg/kg per day for 42 days. Higher doses produced ulceration of the gastrointestinal tract. The emetic dose in dogs is between 150 and 250 mg/kg. Flunixin was well tolerated in monkeys dosed daily with 4 mg/kg for 56 days. No adverse effects occurred in horses dosed orally with 1.0 or 1.5 mg/lb for fifteen consecutive days.

HOW SUPPLIED SECTION

HOW SUPPLIED BANAMINE Paste, 1500 mg is available in a single 30-g syringe.

STORAGE AND HANDLING SECTION

Store below 25°C (77°F). Do not Freeze.

PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Syringe contains flunixin
meglumine equivalent to
1500 mg
FLUNIXIN
Net Wt 30 g

NDC 0061-0214-02

Banamine®
(flunixin meglumine paste)
Paste

For oral use in horses only.
Warning: Do not use in horses intended
for human consumption.
Caution: Federal law restricts this drug to
use by or on the order
of a licensed veterinarian.
Approved by FDA under NADA # 137-409

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label
PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1232453Banamine 0.05 MG/MG Oral PastePSN10
1232453flunixin 0.05 MG/MG Oral Paste [Banamine]SBD10
1232448flunixin 0.05 MG/MG Oral PasteSCD10
1232453Banamine (as flunixin meglumine) 0.05 MG/MG Oral PasteSY10
1232453Banamine 0.05 MG/MG Oral PasteSY10
1232453Banamine 1500 MG per 30 GM Oral PasteSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0061-0214-02Banamine30 g in 1 SYRINGEPASTE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0061-0214BANAMINE (FLUNIXIN MEGLUMINE) PASTE [MERCK SHARP & DOHME CORP.]101 package rows20250503_26d5eb1e-e9f3-4c3f-abb2-fe432cf09353.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Flunixin MeglumineACTIVE INGREDIENT8Y3JK0JW3U2
FlunixinACTIVE MOIETY356IB1O4002
CarboxymethylcelluloseINACTIVE INGREDIENT05JZI7B19X2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V32
Starch, CornINACTIVE INGREDIENTO8232NY3SJ2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0061-02140061-0214-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLUNIXIN MEGLUMINE8Y3JK0JW3UACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 111 matching rows.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.