COCCIAID FOR CALVES- amprolium solution

CocciAid for Calves by

Drug Labeling and Warnings

CocciAid for Calves by is a Animal medication manufactured, distributed, or labeled by Aurora Pharmaceutical, Inc, Zhejiang Dayang Biotech Group Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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CocciAid® for Calves

(amprolium)

9.6% Oral Solution Coccidiostat

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.

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

WITHDRAWAL PERIODS AND RESIDUE WARNINGS: Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

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

PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITATION. For irritations, flush with
plenty of water; get medical attention.

STORAGE AND HANDLING

STORAGE:  Store between 5°-25°C (41°- 7°F) with brief excursions to 40°C.

Benzoic acid 0.1% added as preservative.

Restricted Drug (California) - Use Only as Directed

CocciAid® for Calves

(amprolium)

9.6% Oral Solution Coccidiostat

Net Contents: 1 gal. (128 fl. oz) (3,785 ml)

Active Ingredient: amprolium...............9.6%

Approved by FDA under ANADA # 200-780

Distributed by:

Aurora Pharmaceutical, Inc.

Northfield, MN 55057

PRINCIPAL DISPLAY PANEL

IN 50-1644 rev 03/2024

INGREDIENTS AND APPEARANCE

COCCIAID FOR CALVES 
amprolium solution

Product 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
2	NDC: 51072-110-01	946 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