Banamine ® -S (flunixin meglumine injection)

Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2026-10-26
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-30 01:01:04

Label at a glance#

ProductBanamine-S
Active ingredientFLUNIXIN
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

50 mg/mL

For intramuscular use in swine.
Not for use in breeding swine.

PRODUCT INFORMATION

Approved by FDA under NADA # 101-479

CAUTION

SPL UNCLASSIFIED SECTION

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

DESCRIPTION

DESCRIPTION SECTION

Each milliliter of BANAMINE-S (flunixin meglumine injection) contains 50 mg flunixin (equivalent to 83 mg flunixin meglumine), 0.1 mg edetate disodium, 2.5 mg sodium formaldehyde sulfoxylate, 4.0 mg diethanolamine, 207.2 mg propylene glycol; 5.0 mg phenol as preservative, hydrochloric acid, water for injection q.s.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Flunixin meglumine is a potent non-narcotic, 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.

Flunixin is known to persist in inflammatory tissues1 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentrations2. Therefore, prediction of drug concentrations based upon estimated plasma terminal elimination half-life will likely underestimate both the duration of drug action and the concentration of drug remaining at the site of activity.

The pharmacokinetic profiles were found to follow a 2-compartmental model, although a deep (third) compartment was observed in some animals. The mean terminal elimination half-life (β half-life) of flunixin after a single intramuscular injection of Banamine (2.2 mg/kg) to pigs was between 3 and 4 hours. The mean observed maximum plasma concentration was 2944 ng/mL, achieved at a mean time of approximately 0.4 hours. The mean AUC(0-LOQ) was 6431 ng*hr/mL. Following IM administration of flunixin, quantifiable drug concentration could be measured up to 18 hours post dose. The mean volume of distribution was 2003 mL/kg and the mean total clearance was 390 mL/hr/kg. The mean absolute bioavailability of flunixin following an intramuscular injection in the neck was 87%.

INDICATION

INDICATIONS & USAGE SECTION

BANAMINE-S (flunixin meglumine injection) is indicated for the control of pyrexia associated with swine respiratory disease.

DOSE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

USE WITHIN 28 DAYS OF FIRST PUNCTURE AND PUNCTURE A MAXIMUM OF 10 TIMES. WHEN USING A DRAW-OFF SPIKE OR NEEDLE WITH BORE DIAMETER LARGER THAN 18 GAUGE, DISCARD ANY PRODUCT REMAINING IN THE VIAL IMMEDIATELY AFTER USE.

Note: Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

There are no known contraindications to this drug in swine when used as directed. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration is suspected.

WARNINGS

RESIDUE WARNING SECTION

WITHDRAWAL PERIODS:

SPL UNCLASSIFIED SECTION

Swine must not be slaughtered for human consumption within 12 days of the last treatment.

SPL UNCLASSIFIED SECTION

USER SAFETY WARNINGS: NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN.

Avoid accidental self-injection. Accidental injection of this product may cause swelling, pain, and local irritation. In case of accidental self-injection, consult a physician immediately.

Individuals with known hypersensitivity to NSAIDs should avoid direct contact with the product.

NSAIDs may affect pregnancy. Women who are pregnant, nursing, or may become pregnant should take particular care to avoid self-injection.

Laboratory studies in rats have shown flunixin meglumine to have fetotoxic effects.

This product contains materials that may be irritating to eyes and skin. Avoid direct contact with eyes, skin, and clothing. Do not eat or drink when using the product. Wash hands after use.

Accidental eye exposure may cause irritation, redness, and/or blurred vision. In case of contact with the eyes, flush with water for 15 minutes. If wearing contact lenses, rinse the eyes first then remove contact lenses and continue to rinse. Consult a physician if symptoms occur.

Accidental skin exposure may cause dermatitis (skin irritation and/or burning sensation). In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if dermatitis occurs.

The Safety Data Sheet (SDS) contains more detailed safety information. To obtain a Safety Data Sheet, contact Merck Animal Health at www.merck.com/products/safety-data-sheets/#

PRECAUTIONS

PRECAUTIONS SECTION

As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity.

Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed.

Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of flunixin meglumine with other anti-inflammatory drugs, such as other NSAIDs and corticosteroids, should be avoided.

Not for use in breeding swine. The reproductive effects of BANAMINE-S (flunixin meglumine injection) have not been investigated in this class of swine.

Intramuscular injection may cause local tissue irritation and damage. In an injection site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Flunixin was mildly irritating at the injection sites. No other flunixin-related changes (adverse reactions) were noted in swine administered a 1× (2.2 mg/kg; 1.0 mg/lb) dose for 9 days.

ANIMAL SAFETY

SPL UNCLASSIFIED SECTION

Minimal toxicity manifested itself as statistically significant increased spleen weight at elevated doses (5× or higher daily for 9 days) with no change in normal microscopic architecture.

SPL UNCLASSIFIED SECTION

CONTACT INFORMATION: For technical assistance or to report suspected adverse drug experiences, contact Merck Animal Health at 1-800-211-3573 or www.merck-animal-health-usa.com. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

HOW SUPPLIED

HOW SUPPLIED SECTION

BANAMINE-S (flunixin meglumine injection), 50 mg/mL is available in 100-mL (NDC # 0061-1838-30) multi-dose vials.

STORAGE AND HANDLING SECTION

Store at or below 25°C (77°F). Do not freeze. See the In-Use statement as provided in the Dose and Administration section.

REFERENCES SECTION

1. Lees P, Higgins AJ. Flunixin inhibits prostaglandin E2 production in equine inflammation. Res Vet Sci. 1984; 37:347-349.

2. Odensvik K. Pharmacokinetics of flunixin and its effect on prostaglandin F2α metabolite concentrations after oral and intravenous administration in heifers. J Vet Pharmacol Ther. 1995; 18:254-259.

SPL UNCLASSIFIED SECTION

Distributed by:
Intervet Inc d/b/a Merck Animal Health
Rahway, NJ 07065

Copyright © 2026 Intervet Inc., a subsidiary of Merck & Co., Inc.
All rights reserved.

Formulated in Germany by: Vet Pharma
Friesoythe GmbH

Rev. 02/2026

239058 R9

PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC # 0061-1838-30
Sterile

100 mL
Multiple-Dose Vial
50 mg/mL

Banamine®-S
(flunixin meglumine
injection)

For intramuscular use in swine.
Not for use in breeding swine.

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

Approved by FDA under NADA
# 101-479

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130662858904376GTIN-13: 0662858904376
EAN-13: 0662858904376
GTIN-12: 662858904376
UPC-A: 662858904376
GTIN storage (14 digits): 00662858904376
banamine-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0061-18380061-1838-30

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
FLUNIXIN356IB1O400ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-15full-release2026-06-01 02:43:52

Reported adverse events (FAERS/openFDA)#

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