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
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DOSAGE & ADMINISTRATION
FOR ANIMAL USE ONLY
To prepare 50 Gallons of Medicated Water
For Automatic Water Proportioners
For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water.
Note: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.
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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 solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-901 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM 96 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-901-01 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200496 10/02/2014 Labeler - Aspen Veterinarian Resources Ltd (627265361) Registrant - Bimeda Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda Inc. 060492923 manufacture