Label: COCCIPROL- amprolium solution 

  • Label RSS
  • NDC Code(s): 66104-3624-1, 66104-3624-2
  • Packager: Phibro Animal Health
  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 02/12

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

  • SPL UNCLASSIFIED SECTION

    9.6% Oral Solution

    Coccidiostat

    Water-soluble treatment for coccidiosis ingrowing chickens, laying hens and turkeys.

    Close
  • WARNING: KEEP OUT OF REACH OF CHILDREN.

    NOT FOR HUMAN USE.

    Close
  • ACTIVE INGREDIENT:

    Amprolium 9.6%

    Close
  • INDICATIONS:

    COCCIPROL 9.6% Oral Solution is intended for the treatment of coccidiosis in growing chickens, laying hens, and turkeys. lf 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.

    Close
  • USE DIRECTIONS:

    Give amprolium at the 0.012% level (8 fluid ounces per 50 gallons) for coccidiosis outbreaks as soon as coccidiosis is diagnosed and continue for 3 to 5 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 the treatment period. Use as the sole source of amprolium.

    Close
  • PRECAUTIONS:

    FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITATION.

    Close
  • STORAGE: Store between 5° C (41° F) and 25° C (77° F), excursion permitted up to 40° C (104° F).
  • DESCRIPTION

    Benzoic Acid 0.1% added as a preservative.

    Close
  • DOSAGE & ADMINISTRATION

    DOSAGE LEVEL

    MIXING DIRECTIONS

    0.012%

    To prepare 50 gallons of medicated water at the 0.012% dosage level, pre-mix 1⁄2 pint (8 fluid ounces) Cocciprol with a small volume of water. Then add enough water to make 50 gallons. Stir thoroughly.

    0.024%

    To prepare 50 gallons of medicated water at the 0.024% dosage level, follow the same directions as above but use 1 pint (16 fluid ounces) of CocciproI.

    0.006%

    To prepare 50 gallons of medicated water at the 0.006% dosage level, follow the same directions as above but use 1⁄4 pint (4 fluid ounces) of CocciproI.

    DOSAGE LEVEL

    FOR USE IN AUTOMATIC WATER PROPORTIONERS

    0.012%

    To use COCCIPROL 9.6% Oral Solution in water proportioners to supply 0.012% Amprolium in the drinking water make a stock solution from 20 1⁄2 fluid ounces (2 1⁄2 standard measuring cups) of COCCIPROL 9.6% Oral Solution with sufficient water to make (1) gallon. This stock solution should be used at the rate of one (1) ounce per gallon of drinking water.

    0.006%

    To supply 0.006% Amprolium in the drinking water make a stock solution from 10 1⁄4 fluid ounces (1 1⁄4 standard measuring cups) of COCCIPROL 9.6% Oral Solution with sufficient water to make one (1) gallon and stir thoroughly. Use the stock solution at the rate of one (1) ounce per gallon of drinking water.

    0.024%

    To supply 0.024% Amprolium in the drinking water make a stock solution from 41 fluid ounces (5 standard measuring cups) of COCCIPROL 9.6% Oral Solution with sufficient water to make one (1) gallon and stir thoroughly. Use the stock solution at the rate of one (1) ounce per gallon of drinking water.

    NADA #013-663, Approved by FDA

    Net Contents:

    1 Gallon (3.785 liters)

    101-8129-02

    ® Trademark of Phibro Animal Health, NJ, USA

    Close
  • Principal Display Panel

    Case Label

    Principal Displau Case label

    Jug Label

    Principal Display Jug Label

    Close
  • INGREDIENTS AND APPEARANCE
    COCCIPROL 
    amprolium solution
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:66104-3624
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMPROLIUM (AMPROLIUM) AMPROLIUM 1 L  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66104-3624-2 4 in 1 CASE
    1 NDC:66104-3624-1 3.785 L in 1 JUG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA013663 11/22/2011
    Labeler - Phibro Animal Health (006989008)
    Close