NDC | 46066-123-02, 46066-123-03 |
Set ID | 1f867e4e-86fb-4b37-b532-7213340eba26 |
Category | OTC ANIMAL DRUG LABEL |
Packager | Aspen Veterinary Resources |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NADA120615 |
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DESCRIPTION
Supra Sulfa® III
Antibacterial Sulfamethazine
Sustained Release Bolus (72 hours)
See Caution and Warning on Side Panels
Restricted drug ( California) - Use only as Directed
For Animal Use Only
Keep Out of Reach of Children
NADA 120-615, Approved by FDA
NET CONTENTS: 50 Boluses
EACH BOLUS CONTAINS: Sulfamethazine (formulated in a sustained release base)..................495 grains (32.1 grams)
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INDICATIONS & USAGE
Supra Sulfa® III Boluses (Sulfamethazine Sustained Release Boluses) are intended for oral administration to beef cattle and non-lactating dairy cattle (See Warning). 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 Diptheria (Fusobacterium necrophorum) and Acute Metritis (Streptococcus spp.).
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PRECAUTIONS
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.
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DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: Supra Sulfa®III Boluses (Sulfamethazine Sustained Release Boluses) are designed to be administered orally to beef cattle and non-lactating dairy cattle (See Warning). Supra Sulfa® III Boluses should be given according to the following dosage schedule:
No. of Boluses Animal Body Wgt. No. of Boluses Animal Body Wgt. No. of Boluses Animal Body Wgt. 1 200 lbs 2.5 500 lbs 4 800 lbs 1.5 300 lbs 3 600 lbs 4.5 900 lbs 2 400 lbs 3.5 700 lbs 5 1,000 lbs 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 of 72 hours (3 days). After 72 hours, all animals should be reexamined 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.
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RESIDUE WARNING
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.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUPRA SULFA III
sulfamethazine tablet, extended releaseProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-123 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFAMETHAZINE (UNII: 48U51W007F) (SULFAMETHAZINE - UNII:48U51W007F) SULFAMETHAZINE 32.1 g Product Characteristics Color white Score 2 pieces Shape OVAL Size 83mm Flavor Imprint Code NA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-123-02 50 in 1 BOX 2 NDC:46066-123-03 100 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA120615 03/12/2012 Labeler - Aspen Veterinary Resources (627265361) Registrant - Bimeda Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda Inc. 060492923 manufacture