Label: AMPRID FOR CALVES- amprolium solution

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated January 11, 2023

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  • DESCRIPTION

    Amprid®

    (amprolium)

    9.6% Oral Solution Coccidiostat

    FOR CALVES

    Restricted Drug (California) – Use Only as Directed

    Approved by FDA under ANADA # 200-482

    Net Contents: 1Gallon (128 fl oz) (3.785 L)

    Active Ingredient: amprolium 9.6%

  • INDICATIONS & USAGE

    INDICATIONS: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii 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:

    USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of Amprid FOR CALVES

      5 Day Treatment Protocol

     21 Day Prevention Protocol

    Daily Dosage: 10 mg amprolium/kg

    (10 mg per 2.2 lb body weight)

    Daily Dosage: 5 mg amprolium/kg

    (5 mg per 2.2 lb body weight)

    USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of Amprid FOR CALVES.

    1 fl oz = 29.57 mL

    1 fl oz = 2 measuring tablespoons

    8 fl oz = ½ pint (236.56 mL)

    16 fl oz = 1 pint (473.12 mL)

    IN DRINKING WATER: Mix Amprid FOR CALVES daily with fresh drinking water.

    5-DAY TREATMENT: Add Amprid 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 Amprid 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.

    AS A DRENCH: Amprid 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 Amprid FOR CALVES 9.6% Oral Solution to 1 pt of water and, with a dosage 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) 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 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 Amprid FOR CALVES 9.6% Oral Solution to 1 pt of water and, with a dose syringe, give 1 fl oz of this 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.

  • RESIDUE WARNING

    RESIDUE WARNING: 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

    WARNING: NOT FOR HUMAN USE. Keep this and all drugs out of reach of children.

    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 Bimeda, Inc. at 1-888-524-6332. 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 irritation, flush with plenty of water; get medical attention. 

  • 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.

    Sodium Benzoate 0.1% added as preservative.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    AMPRID FOR CALVES 
    amprolium solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13985-548
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM ION96 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-548-503785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20048211/16/2012
    Labeler - MWI/VetOne (019926120)
    Registrant - Bimeda Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture