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Cocciprol

Phibro Animal Health

Cocciprol(Amprolium)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

9.6% Oral Solution

Coccidiostat

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

NOT FOR HUMAN USE.

ACTIVE INGREDIENT:

Amprolium 9.6%

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.

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.

PRECAUTIONS:

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

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.

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

Principal Display Panel

Case Label

Cocciprol

Jug Label

Cocciprol

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 1 L

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66104-3624-1 3.785 in 1 JUG
2 NDC:66104-3624-2 4 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA013663 2011-11-22


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