Label: AMPROMED FOR CALVES- amprolium solution 

  • NDC Code(s): 61133-8251-3
  • 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

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    AmproMed™ FOR CALVES

    (amprolium)

    9.6% Oral Solution

    Coccidiostat

    FOR ORAL USE IN ANIMAL ONLY

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

    Restricted Drug (California) – Use Only as Directed

    ANADA 200-482, Approved by FDA


    Net Contents:

    1Gallon (128 fl oz) (3.785 L)

    ACTIVE INGREDIENT: amprolium..............9.6%


    INDICATIONS: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii in calves. 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.

    Close
  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:

    USE DIRECTIONS: There are 96 mg of Amprolium in every 1 ml 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)

    1 fl oz = 29.57 mL

    1 fl oz = 2 measuring tablespoonfuls

    Daily Dosage: 5 mg Amprolium/kg

    (5 mg per 2.2 lb body weight)

    8 fl oz = ½ pint (236.56 mL)

    16 fl oz = 1 pint (473.12 mL)

    IN DRINKING WATER

    Mix AmproMed™ FOR CALVES daily with fresh drinking water.

    5-DAY TREATMENT: Add AMPROMED™ FOR CALVES to drinking water at the rate of 16 fl oz/100 gallon. 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. Use 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 PREVENTION: 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 8 fl oz/100 gallon. 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 fl oz AMPROMED™ FOR CALVES to 1 pt (16 oz) of water and, with a dosage syringe, give 1 fl oz of this drench 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. Use 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 PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 fl oz of AMPROMED™ FOR CALVES to 1 pt (16 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.

    Close
  • RESIDUE WARNING

    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.

    Close
  • WARNINGS

    WARNING: Not for Human Use. Keep this and all drugs out of reach of children.

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

    Close
  • PRECAUTIONS

    PRECAUTIONS:MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention. Sodium Benzoate 0.1% add as preserve.

    Close
  • STORAGE AND HANDLING

    STORAGE: Store container in an upright position. Store between 5°C - 25°C (41°F - 77°F), with brief excursions to 40°C.

    Close
  • INGREDIENTS AND APPEARANCE
    AMPROMED FOR CALVES 
    amprolium solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-8251
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMPROLIUM (AMPROLIUM ION) AMPROLIUM ION 96 mg  in 1 mL
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-8251-3 3785 mL in 1 JUG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200482 07/30/2012
    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
    Close