Label: COCCIAID FOR CALVES- amprolium solution
- NDC Code(s): 51072-110-00
- Packager: Aurora Pharmaceutical, Inc
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated May 8, 2024
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VETERINARY INDICATIONS
INDICATIONS FOR USE: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves. For a satisfactory diagnosis a microscopic examination of the feces should be done before treatment. When treating outbreaks, drug should be administered promptly after diagnosis is determined.
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DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION:
5-Day Treatment Protocol 21-Day Prevention Protocol
Daily Dosage: 10 mg amprolium/kg Daily Dosage: 5 mg amprolium/kg
(10 mg per 2.2 lb body weight) (5 mg per 2.2 lb body weight)USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of CocciAid for Calves 9.6% Solution.
1 fl oz = 29.57 mL 8 fl oz = 1/2 pint (236.56 mL)
1 fl oz = 2 measuring tablespoons 16 fl oz = 1 pint (473.12 mL) -
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IN DRINKING WATER
Mix CocciAid for Calves daily with fresh drinking water.
5-DAY TREATMENT: Add CocciAid for Calves 9.6% Oral Solution to drinking water at the rate of 16 fl oz/100 gal. At the usual rate of water consumption this will provide an intake of approximately 10 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 5 days. Use on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated.
21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add CocciAid for Calves 9.6% Oral Solution to drinking water at the rate of 8 fl oz/100 gal. At usual rates of water consumption this will provide an intake of approximately 5 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 21 days.
CocciAid® for Calves is a registered trademark of Aurora Pharmaceutical, Inc.
AS A DRENCH
CocciAid for Calves drench solutions may be stored in a clean, closed, labeled container for up to 3 days.5-DAY TREATMENT: Add 3 fl oz CocciAid for Calves 9.6% Oral Solution to 1 pt of water and, with a dose syringe, give 1 fl oz of this drench solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 10 mg amprolium/kg (2.2 lb) body weight. Give daily for 5 days. Use on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated.
21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 fl oz of CocciAid for Calves 9.6% Oral Solution to 1 pt of water and, with a dose syringe, give 1 fl oz of this drench solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 5 mg amprolium/kg (2.2 lb) body weight. Give daily for 21 days.
Use as the sole source of amprolium.
- RESIDUE WARNING
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WARNINGS
USER SAFETY WARNINGS: NOT FOR HUMAN USE. Keep this and all drugs out of the reach of children.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Aurora Pharmaceutical at 1-888-215-1256 or www.aurorapharmaceutical.com. 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. - PRECAUTIONS
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INGREDIENTS AND APPEARANCE
COCCIAID FOR CALVES
amprolium solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51072-110 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:51072-110-00 3785 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200780 05/08/2024 Labeler - Aurora Pharmaceutical, Inc (832848639) Establishment Name Address ID/FEI Business Operations Aurora Pharmaceutical, Inc 832848639 manufacture Establishment Name Address ID/FEI Business Operations Zhejiang Dayang Biotech Group Co., Ltd. 420600785 api manufacture