Label: AMPROMED-P FOR POULTRY- amprolium solution
- NDC Code(s): 61133-8290-1
- Packager: Bimeda Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated December 12, 2023
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INDICATIONS & USAGE
AmproMed™ P FOR POULTRY
(amprolium)
9.6% Oral Solution Coccidiostat
Water-soluble treatment for coccidiosis
Treats 800 Gallons at 0.012% level.
Restricted Drug (California) – Use Only as Directed
Approved by FDA under ANADA # 200-496
Net Contents:
1 Gallon (128 fl oz) (3.785 L)
Active Ingredient: amprolium..............9.6%
INDICATIONS: AmproMed P FOR POULTRY (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.
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DOSAGE & ADMINISTRATION
USE DIRECTIONS: Give amprolium at the 0.012% level (8 fl oz per 50 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.
FOR ANIMAL USE ONLY
To prepare 50 Gallons of Medicated Water
DOSAGE LEVEL
MIXING DIRECTIONS
0.024 %
Add 1 pint (16 fluid ounces) of AmproMed P FOR POULTRY (amprolium) 9.6% Oral Solution in 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 AmproMed P FOR POULTRY 9.6% Oral Solution.
0.006 %
Follow same directions as above but use 4 fluid ounces of AmproMed P FOR POULTRY 9.6% Oral Solution.
For Automatic Water Portioners
For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water.
DOSAGE LEVEL
AmproMed P FOR POULTRY 9.6 % ORAL SOLUTION
PER GALLON OF STOCK SOLUTION
0.024 %
41 fl oz
0.012 %
20.5 fl oz
0.006 %
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. - WARNINGS
- PRECAUTIONS
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STORAGE AND HANDLING
STORAGE: Store container in an upright position. Store between 5°C - 25°C (41°F - 77°F) with brief excursions to 40°C.
Benzoic acid as Sodium Benzoate 0.1% added as preservative.
The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the SDS contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
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INGREDIENTS AND APPEARANCE
AMPROMED-P FOR POULTRY
amprolium solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-8290 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM ION 96 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-8290-1 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200496 07/30/2012 Labeler - Bimeda Inc. (060492923) Registrant - Bimeda Inc. (060492623) Establishment Name Address ID/FEI Business Operations Bimeda Inc. 060492923 manufacture
