SUPRA SULFA III- sulfamethazine tablet, extended release 
Aspen Veterinary Resources

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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)

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: 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.

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 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:

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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.

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

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SUPRA SULFA III 
sulfamethazine tablet, extended release
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFAMETHAZINE (UNII: 48U51W007F) (SULFAMETHAZINE - UNII:48U51W007F) SULFAMETHAZINE32.1 g
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize83mm
FlavorImprint Code NA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-123-0250 in 1 BOX
2NDC:46066-123-03100 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12061503/12/2012
Labeler - Aspen Veterinary Resources (627265361)
Registrant - Bimeda Inc. (060492923)
Establishment
NameAddressID/FEIBusiness Operations
Bimeda Inc.060492923manufacture

Revised: 10/2023
Document Id: 0ecbfcb6-b7ca-4d4e-91f3-b3fa40ff71d1
Set id: 1f867e4e-86fb-4b37-b532-7213340eba26
Version: 16
Effective Time: 20231011
 
Aspen Veterinary Resources