Label: AMPROMED-P FOR POULTRY- amprolium powder
- NDC Code(s): 61133-8252-1
- Packager: Bimeda, Inc., Division of Cross Vetpharm Group
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- INDICATIONS & USAGE
AmproMed™-P FOR POULTRY
20% Soluble Powder
NOT FOR HUMAN USE
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN
Water Soluble Treatment for Coccidiosis
Contents of each packet will treat 128 gallons at 0.012% level.
Restricted Drug (California) – Use Only as Directed
ANADA 200-488, Approved by FDA
INDICATIONS: AmproMed™ P FOR POULTRY is intended for the treatment of coccidiosis in growing chickens, turkeys and laying hens.
Net Weight: 10 oz (283.5 g)
ACTIVE INGREDIENT: amprolium..............20%
Use Directions: 1 oz = 3 1/2 measuring tablespoonfuls
PREMEASURED 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 AmproMed™ P FOR POULTRY 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% 1/2 bag (5 oz) in 1 gallon
To prepare 50 Gallons of Medicated Water:
DOSAGE LEVEL MIXING DIRECTIONS 0.024% Dissolve 8 ounces of AmproMed™ P FOR POULTRY 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 4 ounces of AmproMed™ P FOR POULTRY 0.006% Follow same directions as above but use 2 ounces of AmproMed™ P FOR POULTRY
Note: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.
USE DIRECTIONS: Give amprolium at the 0.012% level (10 oz AmproMed™ P FOR POULTRY 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 sole source of amprolium.
CAUTION: 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.
- STORAGE AND HANDLING
STORAGE: Store at 20°C - 25° C (68° F - 77 ° F), excursions permitted between 15° C - 30° C (59° F - 86°F).
To obtain an MSDS or for assistance contact Bimeda, Inc. at 1-888-524-6332.
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- INGREDIENTS AND APPEARANCE
AMPROMED-P FOR POULTRY
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-8252 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM ION 56.7 g in 283.5 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-8252-1 283.5 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200488 05/23/2011 Labeler - Bimeda, Inc., Division of Cross Vetpharm Group (060492923) Registrant - Bimeda, Inc., Division of Cross Vetpharm Group (060492923) Establishment Name Address ID/FEI Business Operations Bimeda, Inc., Division of Cross Vetpharm Group 060492923 manufacture Establishment Name Address ID/FEI Business Operations Zhejiang Juizhou 654682061 api manufacture