AmproMed-P FOR POULTRY: Product Information

AMPROMED-P FOR POULTRY- amprolium solution
Bimeda Inc.

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.

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.

WARNING: Keep this and all drugs out of reach of children. NOT FOR HUMAN USE.

PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY.

MAY CAUSE EYE IRRITAION. For irritation, flush with plenty of water; get medical attention.

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.

Manufactured by:

Bimeda, Inc.

Le Sueur, MN 56058

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AMPROMED-P FOR POULTRY
amprolium solution
Product Information
Product Type OTC ANIMAL DRUG 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 Multilevel Packaging
1 NDC:61133-8290-1 3785 mL in 1 JUG None
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 Operations
Bimeda Inc. 060492923 manufacture

Revised: 07/2022 Bimeda Inc.

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