Label: SUPRA SULFA III- sulfamethazine tablet, extended release

  • NDC Code(s): 46066-123-02, 46066-123-03
  • Packager: Aspen Veterinary Resources
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 11, 2023

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  • DESCRIPTION

    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

    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

    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

    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

    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.

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    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