Label: AMPROL 128- amprolium powder

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

Drug Label Information

Updated December 29, 2022

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

  • SPL UNCLASSIFIED SECTION

    AMPROL® 128

    (amprolium)

    20% Soluble Powder
    Coccidiostat

    Water-Soluble Treatment for Coccidiosis
    Contents of each packet will treat
    128 gallons at 0.012% level

  • ACTIVE INGREDIENT

    Net Contents: 10 oz. (283.5 grams)
    Active Ingredient: amprolium...........20%

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Huvepharma, Inc.
    Peachtree City, GA 30269

    For questions, please call 1-877-994-4883

    Approved by FDA under NADA # 033-165

  • VETERINARY INDICATIONS

                         FOR ANIMAL USE ONLY

    INDICATIONS FOR USE: AMPROL® 128 (amprolium)
    20% Soluble Powder is intended for the treatment
    of coccidiosis in growing chickens, turkeys, and
    laying hens.

  • PRECAUTIONS

    CAUTION: If no improvement is noted within 3 days, have the diagnosis reconfirmed 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.

  • RESIDUE WARNING

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

  • USER SAFETY WARNINGS

    USER SAFETY WARNING: Not for Human Use. Keep out of reach of children.

  • STORAGE AND HANDLING

    STORAGE: Store between 5º - 25ºC (41º - 77ºF) with brief excursions to 40ºC (104ºF). Avoid high
    humidity storage conditions.

  • INDICATIONS & USAGE

    USE DIRECTIONS: Give amprolium at the 0.012% level (10 oz AMPROL 128 20% Soluble Powder per
    128 gallons) as soon as coccidiosis is diagnosed and continue for three to five 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.

    Restricted Drug (California) – Use Only as Directed.

  • SPL UNCLASSIFIED SECTION

    Lot No & Exp Date

    Take Time

  • DOSAGE & ADMINISTRATION

    PREMEASURED FOR AUTOMATIC

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

    To prepare

    dosage levels of:

       Dissolve AMPROL 128

       (amprolium) 20% Soluble Powder

       in one gallon of water.

       (Makes 1 gallon of stock solution.)

    0.024%

       2 bags (20 oz) in 1 gallon

    0.012%

       1 bag (10 oz) in 1 gallon

    0.006%

       ½ bag (5 oz) in 1 gallon

    To Prepare 50 Gallons of Medicated Water

    DOSAGE LEVEL

       MIXING DIRECTIONS

    0.024%

       Dissolve 8 ounces of AMPROL 128 20% Soluble Powder in about 5 gallons of water in a 50-gallon

       medicated barrel. Stir, then add water to the 50-gallon mark. Stir thoroughly.

    0.012%

       Follow same directions as above but use 4 ounces of AMPROL 128 20% Soluble Powder.

    0.006%

       Follow same directions as above but use 2 ounces of AMPROL 128 20% Soluble Powder.

  • SPL UNCLASSIFIED SECTION

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

    AMPROL® is a registered trademark of Huvepharma, Inc.

  • PRINCIPAL DISPLAY PANEL

    Amprol_128_Pouch_Label_04-2022.jpg

  • INGREDIENTS AND APPEARANCE
    AMPROL  128
    amprolium powder
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:23243-9709
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM0.2 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-9709-3283.5 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03316506/06/2018
    Labeler - Huvepharma, Inc. (619153559)
    Registrant - Huvepharma EOOD (552691651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc.883128204pack, label, manufacture, analysis, medicated animal feed manufacture