AMPROMED-P FOR POULTRY- amprolium solution

AmproMed-P FOR POULTRY by

Drug Labeling and Warnings

AmproMed-P FOR POULTRY by is a Animal medication manufactured, distributed, or labeled by Bimeda Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

ANADA 200-496, Approved by FDA

Net Contents:

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.

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.

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.

WARNINGS

WARNING: Keep this and all drugs out of reach of children.

NOT FOR HUMAN USE

PRECAUTIONS

PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITAION. For irritation, flush with pleanty of water; get medical attention.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMPROMED-P FOR POULTRY 
amprolium solution

Product 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