Label: AMPROMED-P FOR POULTRY- amprolium solution
- NDC Code(s): 61133-8290-1
- 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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- DOSAGE & ADMINISTRATION
AmproMed™- P FOR POULTRY
9.6% Oral Solution
Water soluble treatment for coccidiosis
Treats 800 Gallons at 0.012% level.
Restricted Drug (California) – Use Only as Directed
ANADA 200-496, Approved by FDA
1Gallon (128 fl oz) (3.785 L)
ACTIVE INGREDIENT: amprolium..............9.6%
FOR ANIMAL USE ONLY
To prepare 50 Gallon of Medicated Water
DOSAGE LEVEL MIXING DIRECTIONS 0.024 % Add 1 pint (16 fluid ounces) of AmproMed™ P FOR POULTRY 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.
PREMEASURED FOR AUTOMATIC WATER PROPORTIONERS:
For use in automatic water proportioners that meter 1 fluid ounce of stock solution for per gallon of drinking water.
TO PREPARE DOSAGE LEVELS OF
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.
Benzoic acid as Sodium Benzoate 0.1% added as preservative.Close
- 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.
To obtain an MSDS or for asistance contact Bimeda, Inc., at 1-888-524-6332.Close
- INDICATIONS & USAGE
INDICATIONS:AmproMed™ P FOR POULTRY 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.
USE DIRECTIONS: Give amprolium at the 0.012% level (8fl oz AmproMed™ P FOR POULTRY 9.6% Oral Solution 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.Close
WARNING: Keep this and all drugs out of reach of children.
NOT FOR HUMAN USEClose
PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITAION. For irritation, flush with pleanty of water; get medical attention.Close
- INGREDIENTS AND APPEARANCE
AMPROMED-P FOR POULTRY
Product Information Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-8290 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPROLIUM (AMPROLIUM ION) 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., Division of Cross Vetpharm Group (060492923) Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492623) Establishment Name Address ID/FEI Business Operations Bimeda Inc., division of Cross Vetpharm Group 060492923 manufacture Establishment Name Address ID/FEI Business Operations Zhejiang Jiuzhou 654682061 api manufacture