Label: COCCIAID- amprolium solution

  • NDC Code(s): 51072-090-00
  • Packager: Aurora Pharmaceutical, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated December 3, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    NDC 51072-090-00

    CocciAid®

    (amprolium)

    9.6% Oral Solution

    Coccidiostat

    Water-soluble treatment for coccidiosis

    Treats 800 gallons at 0.012% level

    Approved by FDA under ANADA # 200-630

    Net Contents:

    1 Gallon (128 fl oz) (3.785 L)

  • Active Ingredient:

    amprolium.........9.6%

  • INDICATIONS:

    CocciAid® (amprolium) 9.6% Oral Solution is intended for the treatment of coccidiosis in growing chickens, turkeys, and laying hens. If no improvement is noted within 3 days, have the diagnosis confirmed and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions.

  • USE DIRECTIONS:

    Give amprolium at the 0.012% level (8 fl oz per 50 gallons) as soon as coccidiosis is diagnosed and continue for 3 to 5 days. (In severe outbreaks, give amprolium at the 0.024% level.) Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks. No other source of drinking water should be available to the birds during this time. Use as the sole source of amprolium.

  • WARNING:

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

  • PRECAUTIONS:

    FOR ORAL USE IN ANIMALS ONLY.
    MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention.
    Restricted Drug (California) — Use Only as Directed

  • STORAGE:

    Store between 5°–25°C (41°–77°F) with brief excursions to 40°C.

  • SPL UNCLASSIFIED SECTION

    Benzoic acid 0.1% added as preservative.

  • QUESTIONS

    For questions, please call 1-888-215-1256.

  • DOSAGE & ADMINISTRATION

    FOR ANIMAL USE ONLY
    To Prepare 50 Gallons of Medicated Water

    DOSAGE LEVELMIXING DIRECTIONS
    0.024%Add 1 pint (16 fluid ounces) of CocciAid​® (amprolium) 9.6% Oral Solution to about 5 gallons of water in a 50-gallon medication barrel. Stir, then add water to the 50-gallon mark. Stir thoroughly.
    0.012%Follow same directions as above but use 1/2 pint (8 fluid ounces) of CocciAid​® 9.6% Oral Solution.
    0.006%Follow same directions as above but use 4 fluid ounces of CocciAid​® 9.6% Oral Solution.

    For Automatic Water Proportioners
    For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water.

    DOSAGE LEVELCOCCIAID® 9.6% ORAL SOLUTION
    PER GALLON OF STOCK SOLUTION
    0.024%
    0.012%
    0.006%
    41 fl oz
    20.5 fl oz
    10.25 fl oz

    Note: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.

  • SPL UNCLASSIFIED SECTION

    REORDER NO: 24001
    Aurora Pharmaceutical, Inc.
    NORTHFIELD, MN 55057
    1-888-215-1256
    www.aurorapharmaceutical.com
    IN 50-1465  10/2020

    image description

  • Container Label

    PRINCIPAL DISPLAY PANEL - 1 gallon bottle label

    Principal Display Panel Left

    Principal Display Panel Right

  • INGREDIENTS AND APPEARANCE
    COCCIAID 
    amprolium solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM96   in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51072-090-003785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20063008/23/2018
    Labeler - Aurora Pharmaceutical, Inc. (832848639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurora Pharmaceutical, Inc.832848639manufacture