Label: AMPROMED-P FOR POULTRY- amprolium solution

  • NDC Code(s): 61133-8290-1
  • 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 08/13

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  • DOSAGE & ADMINISTRATION

    AmproMed™- P FOR POULTRY 

    (amprolium)      

    9.6% Oral Solution

    Coccidiostat


    Water soluble treatment for coccidiosis

    Treats 800 Gallons at 0.012% level.

    Restricted Drug (California) – Use Only as Directed

    ANADA 200-496, Approved by FDA

    Net Contents:

    1Gallon (128 fl oz) (3.785 L)

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

    FOR ANIMAL USE ONLY

    To prepare 50 Gallon of Medicated Water

    DOSAGE LEVEL MIXING DIRECTIONS
    0.024 % Add 1 pint (16 fluid ounces) of AmproMed™ P FOR POULTRY 9.6% Oral Solution in about 5 gallons of water in a 50 gallon medication barrel. Stir, then add water to the 50 gallon mark. Stir thoroughly.
    0.012 % Follow same directions as above but use 1/2 pint ( 8 fluid ounces) of AmproMed™ P FOR POULTRY 9.6% Oral Solution.
    0.006 % Follow same directions as above but use 4 fluid ounces of AmproMed™ P FOR POULTRY 9.6% Oral Solution.

    PREMEASURED FOR AUTOMATIC WATER PROPORTIONERS:

    For use in automatic water proportioners that meter 1 fluid ounce of stock solution for per gallon of drinking water.

    TO PREPARE DOSAGE LEVELS OF

    AmproMed™ P FOR POULTRY 9.6 % Oral Solution

                      PER GALLON OF STOCK SOLUTION

     0.024 %  41 fl oz
     0.012 %  20.5 fl oz
     0.006 %  10.25 fl oz


    NOTE: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.

    Benzoic acid as Sodium Benzoate 0.1% added as preservative.

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  • 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.               

    To obtain an MSDS or for asistance contact Bimeda, Inc., at 1-888-524-6332.

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  • INDICATIONS & USAGE

    INDICATIONS:AmproMed™ P FOR POULTRY 9.6 % Oral Solution is intended for the treatment of coccidiosis in growing chickens, turkeys, and laying hens. If no improvement is noted within 3 days, have the diagnosis confirmed and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions.

    USE DIRECTIONS: Give amprolium at the 0.012% level (8fl oz AmproMed™ P FOR POULTRY 9.6% Oral Solution per 50 gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024 % level). Continue with 0.006 % amprolium medicated water for an additional 1 to 2 weeks. No other source of drinking water should be available to the birds during this time.

    Use as the sole source of amprolium.

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  • WARNINGS

    WARNING: Keep this and all drugs out of reach of children.

    NOT FOR HUMAN USE

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  • PRECAUTIONS

    PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITAION. For irritation, flush with pleanty of water; get medical attention.

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  • INGREDIENTS AND APPEARANCE
    AMPROMED-P FOR POULTRY 
    amprolium solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-8290
    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
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-8290-1 3785 mL in 1 JUG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200496 07/30/2012
    Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
    Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492623)
    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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