Label: AMPROL 128- amprolium powder
- NDC Code(s): 23243-9709-3
- Packager: Huvepharma, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated December 29, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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- VETERINARY INDICATIONS
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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
- USER SAFETY WARNINGS
- STORAGE AND HANDLING
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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.
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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.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMPROL 128
amprolium powderProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:23243-9709 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM 0.2 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23243-9709-3 283.5 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA033165 06/06/2018 Labeler - Huvepharma, Inc. (619153559) Registrant - Huvepharma EOOD (552691651) Establishment Name Address ID/FEI Business Operations Huvepharma, Inc. 883128204 pack, label, manufacture, analysis, medicated animal feed manufacture