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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  • SPL UNCLASSIFIED SECTION

    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)

  • SPL UNCLASSIFIED SECTION

                                           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

  • PRINCIPAL DISPLAY PANEL

    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

    IN 50-1644 rev 03/2024

    Front Bottle

  • INGREDIENTS AND APPEARANCE
    COCCIAID FOR CALVES 
    amprolium solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM96 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51072-110-003785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20078005/08/2024
    Labeler - Aurora Pharmaceutical, Inc (832848639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurora Pharmaceutical, Inc832848639manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dayang Biotech Group Co., Ltd.420600785api manufacture