Label: AMPROL- amprolium solution
- NDC Code(s): 23243-6681-2
- Packager: Huvepharma, Inc
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated February 28, 2023
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- Official Label (Printer Friendly)
- FRONT PANEL
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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
- USER SAFETY WARNINGS
- PRECAUTIONS
- STORAGE AND HANDLING
- ADVERSE REACTIONS
- SPL UNCLASSIFIED SECTION
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DOSAGE FORMS & STRENGTHS
FOR ANIMAL USE ONLY
To prepare 50 Gallons of Medicated Water
DOSAGE LEVEL MIXING 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 LEVEL AMPROL 9.6% ORAL SOLUTION PER
GALLON OF STOCK SOLUTION0.024%
0.012%
0.006%41 fl oz
20.5 fl oz
10.25 fl ozNote: 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMPROL
amprolium solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:23243-6681 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM 96 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23243-6681-2 4 in 1 BOX 1 3785 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA013149 06/29/2009 Labeler - Huvepharma, Inc (619153559) Registrant - Huvepharma EOOD (552691651) Establishment Name Address ID/FEI Business Operations Huvepharma, Inc - St. Louis 883128204 analysis, label, manufacture, medicated animal feed manufacture, pack