SUPRA SULFA III (SULFAMETHAZINE) TABLET, EXTENDED RELEASE [ASPEN VETERINARY RESOURCES]

SUPRA SULFA III (SULFAMETHAZINE) TABLET, EXTENDED RELEASE [ASPEN VETERINARY RESOURCES]
PDF | XML

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
  • 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)

  • 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.).

  • 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.

  • 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.

  • 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

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUPRA SULFA III 
    sulfamethazine tablet, extended release
    Product Information
    Product TypeOTC 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

Related Drugs