Label: AMPROL- amprolium solution

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

Drug Label Information

Updated February 28, 2023

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

  • FRONT PANEL

    AMPROL®

    (amprolium)

    9.6% Oral Solution

    Coccidiostat

    Water-soluble treatment for coccidiosis

    Treats 800 Gallons at 0.012% level

    Product # 09568A

    Net Contents: 128 fl.oz (1 gal.) (3.785 L)

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

    1022-1814-03 Rev. 09-2022

  • VETERINARY INDICATIONS

    INDICATIONS FOR USE: AMPROL® (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.

  • INSTRUCTIONS FOR USE

    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.

  • RESIDUE WARNING

    WITHDRAWAL PERIODS: No withdrawal period is required when used according to labeling.

  • USER SAFETY WARNINGS

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

  • PRECAUTIONS

    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 AND HANDLING

    STORAGE: Store between 5º - 25ºC (41º - 77ºF) with brief excursions to 40ºC.
    Benzoic acid 0.1% added as preservative.

  • ADVERSE REACTIONS

    Contact Huvepharma Inc. at 1-877-994-4883 or http://www.huvepharma.us. For additional
    information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or
    http://www.fda.gov/reportanimalae.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Huvepharma, Inc.
    525 Westpark Drive, Suite 230
    Peachtree City, GA 30269
                                                                            ®AMPROL is a registered
    Approved by FDA under NADA # 013-149    trademark of Huvepharma, Inc

  • DOSAGE FORMS & STRENGTHS

                   FOR ANIMAL USE ONLY

                To prepare 50 Gallons of Medicated Water

    DOSAGE LEVELMIXING DIRECTIONS
    0.024%Add 1 pint (16 fluid ounces) of AMPROL (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 AMPROL 9.6% Oral Solution
    0.006%Follow same directions as above but use 4 fluid ounces of AMPROL 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 LEVELAMPROL 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.

    See bottle for Lot No.
    and Exp. Date

  • SPL UNCLASSIFIED SECTION

    Take Time Image

  • PRINCIPAL DISPLAY PANEL

    Amprol 1 gallon bottle

  • INGREDIENTS AND APPEARANCE
    AMPROL 
    amprolium solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:23243-6681
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM96 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-6681-24 in 1 BOX
    13785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01314906/29/2009
    Labeler - Huvepharma, Inc (619153559)
    Registrant - Huvepharma EOOD (552691651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc - St. Louis883128204analysis, label, manufacture, medicated animal feed manufacture, pack