Supra Sulfa III

Manufacturer
Aspen Veterinary Resources | Bimeda Inc.
Effective date
2023-10-11
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 21:22:53

Label at a glance#

ProductSupra Sulfa III
Active ingredientSULFAMETHAZINE
Label structure7 sections

Storage and handling

Store at 20°C - 25°C (68° - 77°F), with excursions permitted to 15°C - 30°C (59° F - 86°F).

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Supra Sulfa® III
(sulfamethazine)
SUSTAINED RELEASE BOLUS (72 HOURS)
Antibacterial
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NOT FOR HUMAN USE
KEEP OUT OF REACH OF CHILDREN
Approved by FDA under NADA # 120-615

Net Contents: 50 Boluses
EACH BOLUS CONTAINS: Sulfamethazine (formulated in a sustained release base), 495 grains (32.1 grams)

INDICATIONS & USAGE SECTION

Supra Sulfa® III Boluses (sulfamethazine) are intended for oral administration to beef cattle and non-lactating dairy cattle (See RESIDUE WARNING Statement). Supra Sulfa® III Boluses are indicated for the treatment of the following diseases when caused by one or more of the following pathogenic organisms sensitive to sulfamethazine: Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex) (Pasteurella spp.), Colibacillosis (Bacterial Scours) (E. Coli), Necrotic pododermatitis (Foot Rot), Calf Diphtheria (Fusobacterium necrophorum), Acute Metritis (Streptococcus spp.).

RESIDUE WARNING SECTION

RESIDUE WARNING: Treated animals intended for human consumption should not be slaughtered for food for at least 12 days after the last dose. Exceeding two (2) consecutive doses may cause violative tissue residues to remain beyond the withdrawal time. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. Do not use in calves under one (1) month of age or calves being fed an all-milk diet. Use in these classes of calves may cause violative residues to remain beyond the withdrawal time.

PRECAUTIONS SECTION

CAUTION: This drug, like all sulfonamides, may cause toxic reactions and irreparable injury unless administered with adequate and continuous supervision; follow recommended dosages carefully.

Fluid intake must be adequate at all times throughout the three-day therapy provided by the sustained release bolus. This product has not been shown to be effective for non-ruminating calves.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION: Supra Sulfa® III Boluses (sulfamethazine) are designed to be administered orally to beef cattle and non-lactating dairy cattle (See RESIDUE WARNING Statement). Supra Sulfa® III Boluses should be given according to the following dosage schedule:

image descriptionimage description

This bolus may be divided for better approximation of correct dose; however, care should be taken not to crush the bolus. Care should also be taken to ensure the entire dose has been swallowed by the animal. Observe animals following administration to ensure boluses are not regurgitated. Lubricate bolus before dosing animals.

Supra Sulfa® III Boluses are designed to provide a therapeutic sulfamethazine level in approximately 6 hours and persist in providing this level for 72 hours (3 days). After 72 hours, all animals should be re-examined for persistence of observable disease signs. If signs are present, consult a veterinarian. It is strongly recommended that a second dose be given to provide for an additional 72 hours of therapy particularly in those more severe cases. The dosage schedule should be used at each 72 hour interval.

STORAGE AND HANDLING SECTION

Store at 20°C - 25°C (68° - 77°F), with excursions permitted to 15°C - 30°C (59° F - 86°F).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46066-123SUPRA SULFA III (SULFAMETHAZINE) TABLET, EXTENDED RELEASE [ASPEN VETERINARY RESOURCES]16Unmatched20231031_1f867e4e-86fb-4b37-b532-7213340eba26.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFAMETHAZINEACTIVE INGREDIENT48U51W007F8
SULFAMETHAZINEACTIVE MOIETY48U51W007F8

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
46066-12346066-123-02, 46066-123-03

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
SULFAMETHAZINE48U51W007FACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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