Label: AMPROMED FOR CALVES- amprolium powder

  • NDC Code(s): 61133-8250-1
  • Packager: Bimeda, Inc., Division of Cross Vetpharm Group
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

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  • DOSAGE & ADMINISTRATION

    AmproMed™ FOR CALVES 

    (amprolium)

    20% Soluble Powder

    Coccidiostat

    FOR ANIMAL USE ONLY

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN


    Restricted Drug (California) – Use Only as Directed

    ANADA 200-464, Approved by FDA


    INDICATION: An Aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves.

    Net Contents:

    25 lb (11.34 kg)

    ACTIVE INGREDIENT: amprolium..............20%

    Use Directions: There are 220 mg of amprolium in every 1 gram of AMPROMED FOR CALVES

     5-Day Treatment Protocol 21-Day Prevention Protocol 

    Daily Dosage: 10 mg amprolium/kg

    (10 mg per 2.2 lb body weight)

    Daily Dosage: 10 mg amprolium/kg

    (10 mg per 2.2 lb body weight)

     1 oz=3 1/2 measuring tablespoonfuls  1 oz=28.35 grams

    In Drinking Water: Mix AMPROMED FOR CALVES daily with fresh drinking water. Stock solution for water proportioners may be stored in a clean, closed, labeled container for up to 3 days.

    5-DAY TREATMENT: Add AMPROMED FOR CALVES to drinking water at the rate of 4 oz/50 gallon. One 10 oz pack to 125 gallons of water. For use in automatic water proportioners that meter 1 fl oz of stock solution per gallon of drinking water, add 1 pouch (10 oz) in 1 gallon of water to make stock solution. At the usual rate of water consumption, this will provide an intake of approximately 10 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 5 days. Treatment should be on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated.

    21-DAY TREATMENT: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add AMPROMED FOR CALVES to drinking water at the rate of 4 oz/100 gallon. One 10 oz pack to 250 gallons of water. For use in automatic water proportioners that meter 1 fl oz of stock solution per gallon of drinking water, add 1/2 pouch (5 oz) in 1 gallon of water to make stock solution. At usual rates of water consumption, this will provide an intake of approximately 5 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 21 days.

    As a Drench: AMPROMED FOR CALVES drench solutions may be stored in a clean, labeled container for up to 3 days.

    5-DAY TREATMENT: Add 3 oz AMPROMED FOR CALVES to 1 qt (32 fl oz) of water and, with a dosage syringe, give 1 fl oz of this solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 10 mg amprolium/kg (2.2) body weight. Give daily for 5 days. Treatment should be on a herd basis only: when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves should be treated.

    21-DAY TREATMENT: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 oz AMPROMED FOR CALVES to 1 qt (32 fl oz) of water and, with a dose syringe, give 1 fl oz of this solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 5 mg amprolium/kg (2.2 lb) body weight. Give daily for 21 days.

    CAUTION: For a satisfactory diagnosis a microscopic examination of the feces should be done before treatment. When treating outbreaks, drug should be administered promptly after diagnosis is determined.

    RESIDUE WARNING: Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

    STORAGE: Store at 20°C - 25°C (68°F - 77°F), excursions permitted between 15°C - 30°C (59°F - 86°F),

    The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain MSDS contact Bimeda, Inc. at 1-888-524-6332.

    HOW SUPPLIED: 10 oz Pouches and 25 lb Pail.

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  • INGREDIENTS AND APPEARANCE
    AMPROMED FOR CALVES 
    amprolium powder
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-8250
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMPROLIUM (AMPROLIUM ION) AMPROLIUM ION 220 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-8250-1 283.5 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200464 05/23/2011
    Labeler - Bimeda, Inc., Division of Cross Vetpharm Group (060492923)
    Registrant - Bimeda, Inc., Division of Cross Vetpharm Group (060492923)
    Establishment
    Name Address ID/FEI Business Operations
    Bimeda, Inc., Division of Cross Vetpharm Group 060492923 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Zhejiang Jiuzhou 654682061 api manufacture
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