Label: AMPROMED-P FOR POULTRY- amprolium powder

  • NDC Code(s): 61133-8252-1
  • 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

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

  • INDICATIONS & USAGE

    AmproMed™-P FOR POULTRY

    (amprolium)

    20% Soluble Powder
    Coccidiostat

    NOT FOR HUMAN USE
    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

    Water Soluble Treatment for Coccidiosis

    Contents of each packet will treat 128 gallons at 0.012% level.

    Restricted Drug (California) – Use Only as Directed

    ANADA 200-488, Approved by FDA

    INDICATIONS: AmproMed™ P FOR POULTRY is intended for the treatment of coccidiosis in growing chickens, turkeys and laying hens.

    Net Weight: 10 oz (283.5 g)

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

    Use Directions: 1 oz = 3 1/2 measuring tablespoonfuls

    PREMEASURED FOR AUTOMATIC WATER PROPORTIONERS: For use in automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water.

    To prepare dosage levels of Dissolve AmproMed™ P FOR POULTRY in one gallon of water. (Makes 1 gallon of stock solution.)
    0.024% 2 bags (20 oz) in 1 gallon
    0.012% 1 bag (10 oz) in 1 gallon
    0.006% 1/2 bag (5 oz) in 1 gallon

    To prepare 50 Gallons of Medicated Water:

     DOSAGE LEVEL  MIXING DIRECTIONS
     0.024%  Dissolve 8 ounces of AmproMed™ P FOR POULTRY 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 4 ounces of AmproMed™ P FOR POULTRY
     0.006%  Follow same directions as above but use 2 ounces of AmproMed™ P FOR POULTRY

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

    USE DIRECTIONS: Give amprolium at the 0.012% level (10 oz AmproMed™ P FOR POULTRY per 128 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 sole source of amprolium.

    CAUTION: 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.

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  • STORAGE AND HANDLING

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

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

    Take Time Observe Label Directions

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  • INGREDIENTS AND APPEARANCE
    AMPROMED-P FOR POULTRY 
    amprolium powder
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-8252
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMPROLIUM (AMPROLIUM ION) AMPROLIUM ION 56.7 g  in 283.5 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-8252-1 283.5 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200488 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 Juizhou 654682061 api manufacture
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