Animal NDC 51072-110-01 Cocciaid For Calves

Amprolium

Animal Product Information

Field Name Field Value
Animal NDC Code 51072-110-01
Proprietary Name Cocciaid For Calves What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Amprolium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Aurora Pharmaceutical, Inc
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Amprolium
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200780 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Cocciaid For Calves Images

Cocciaid For Calves Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



CocciAid® for Calves

(amprolium)

9.6% Oral Solution Coccidiostat

                                       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.

Approved by FDA under ANADA # 200-780

Distributed by:

Aurora Pharmaceutical, Inc.

Northfield, MN 55057


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)


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)


Otc - Active Ingredient



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


Package Label.Principal Display Panel



IN 50-1644 rev 03/2024


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.