Label: COCCI CURE P FOR POULTRY- amprolium solution

  • NDC Code(s): 46066-901-01
  • Packager: Aspen Veterinarian Resources Ltd
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated December 12, 2023

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  • DESCRIPTION

    Cocci-Cure® P FOR POULTRY
    (amprolium)
    9.6% Oral Solution
    Coccidiostat
    Active ingredient: amprolium...........9.6%
    Water-soluble treatment for coccidiosis
    Treats 800 Gallons at 0.012% level
    Restricted Drug (California) - Use Only as Directed
    Approved by FDA under ANADA # 200-496
    Net Contents: 1 Gallon (128 fl oz)(3.785 L)

  • INDICATIONS & USAGE

    INDICATIONS: Cocci-Cure® P FOR POULTRY (amprolium) 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 (8 fl oz 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.

  • WARNINGS AND PRECAUTIONS

    WARNING: Keep this and all drugs out of reach of children. NOT FOR HUMAN USE.

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

  • DOSAGE & ADMINISTRATION

    FOR ANIMAL USE ONLY

    To prepare 50 Gallons of Medicated Water

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    For Automatic Water Proportioners

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

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

  • 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.

    Benzoic acid as Sodium Benzoate 0.1% added as preservative.

    The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the SDS, contact the manufacturer at 1-800-792-1238. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    COCCI CURE P FOR POULTRY 
    amprolium solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-901
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM96 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-901-013785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20049610/02/2014
    Labeler - Aspen Veterinarian Resources Ltd (627265361)
    Registrant - Bimeda Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda Inc.060492923manufacture