Label: COCCIPROL- amprolium solution
- 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.
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- SPL UNCLASSIFIED SECTION
9.6% Oral Solution
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:
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
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).
Benzoic Acid 0.1% added as a preservative.Close
- DOSAGE & ADMINISTRATION
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.
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.
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.
FOR USE IN AUTOMATIC WATER PROPORTIONERS
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.
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.
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
1 Gallon (3.785 liters)
® Trademark of Phibro Animal Health, NJ, USAClose
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- INGREDIENTS AND APPEARANCE
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)