Label: SUSTAIN III- sulfamethazine tablet

  • NDC Code(s): 61133-1331-1, 61133-1331-2, 61133-1331-3
  • Packager: Bimeda, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 5, 2018

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  • DOSAGE & ADMINISTRATION

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

    No. of Boluses    Animal Body Weight

         1                                                                   200 lbs.


         1.5                                                                300 lbs.


         2                                                                   400 lbs.


         2.5                                                                500 lbs.


         3                                                                   600 lbs.


         3.5                                                                700 lbs.


         4                                                                   800 lbs.


         4.5                                                                950 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 Sustain III® before dosing animals.

    Sustain 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 your 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.

    Fluid intake must be adequate at all times throughout the three-day therapy provided by the sustained release bolus.

  • STORAGE AND HANDLING

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

  • DESCRIPTION

    EACH BOLUS CONTAINS: Sulfamethazine (formulated in a sustained release base) 495 grains (32.1 grams)

    Sustain III® Boluses (Sulfamethazine Sustained Release Boluses) are intended for oral administration to beef cattle and non-lactating dairy cattle (See RESIDE WARNING Statement). Sustain 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.).

  • PRECAUTIONS

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

  • 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.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SUSTAIN III  
    sulfamethazine tablet
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-1331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfamethazine (UNII: 48U51W007F) (SULFAMETHAZINE - UNII:48U51W007F) Sulfamethazine32.1 g
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize1935mm
    FlavorImprint Code NA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-1331-2100 in 1 CARTON
    2NDC:61133-1331-110 in 1 CARTON
    3NDC:61133-1331-350 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12061507/14/1984
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture