AMPROL- amprolium solution

Amprol by

Drug Labeling and Warnings

Amprol by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Huvepharma EOOD, Huvepharma, Inc - St. Louis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRONT PANEL

AMPROL®

(amprolium)

9.6% Oral Solution

Coccidiostat

Water-soluble treatment for coccidiosis

Treats 100 Gallons at 0.012% level

Product # 66819

Net Contents: 16 fl.oz (473 mL)

Active Ingredient: Amprolium............9.6%

Distributed by:

Huvepharma, Inc.

525 Westpark Drive, Suite 230

Peachtree City, GA 30269                HUVEPHARMA

INDICATIONS

Amprol (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 3 to 5 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

WARNING:

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

PRECAUTIONS:

FOR ORAL USE IN ANIMALS ONLY.

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

Restricted Drug (California) - Use Only as Directed.

STORAGE AND HANDLING

STORAGE: Store between 50 - 250C (410 - 770F) with brief excursions to 400C.

Benzoic acid 0.1% added as preservative.

For questions, please call 1-877-4AMPROL

NADA 013-149

Approved by FDA                        Lot No and Exp. Date

DOSAGE AND MIXING DIRECTIONS

FOR ANIMAL USE ONLY

To prepare 50 Gallons of Medicated Water

• DOSAGE LEVEL: MIXING DIRECTIONS
• 0.024%: Add 1 pint (16 fluid ounces) of AMPROL (amprolium 9.6% Oral Solution to 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; AMPROL 9.6% Oral Solution
• 0.006%: Follow same directions as above but use 4 fluid ounces of AMPROL 9.6%; Oral Solution

For Automatic Water Proportioners
For automatic water proportioners that meter 1 fluid ounce
of stock solution per gallon of drinking water.

• DOSAGE LEVEL: AMPROL 9.6% ORAL SOLUTION PER; GALLON OF STOCK SOLUTION
• 0.024%0.012%0.006%: 41 fl oz; 20.5 fl oz; 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

SPL UNCLASSIFIED SECTION

Principal Display Panel - 1 Gallon Bottle Label

INGREDIENTS AND APPEARANCE

AMPROL 
amprolium solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 23243-6681
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)	AMPROLIUM	96 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-6681-1	12 in 1 BOX
1		473 mL in 1 BOTTLE, PLASTIC
2	NDC: 23243-6681-2	4 in 1 BOX
2		3785 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA013149	06/29/2009

Labeler - Huvepharma, Inc (619153559)

Registrant - Huvepharma EOOD (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc - St. Louis		883128204	analysis, label, manufacture, medicated animal feed manufacture, pack