AMPROL 128- amprolium powder

Amprol by

Drug Labeling and Warnings

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

Drug Details [pdf]

INDICATIONS

AMPROL 128 (amprolium) 20% Soluble Powder is intended for the treatment of coccidiosis in growing chickens, turkeys and laying hens.

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.

WARNINGS AND PRECAUTIONS

NOT FOR HUMAN USE. Resticted Drug (California)-Use only as directed. Keep this and all drugs out of the reach of children.

STORAGE:

Store between 5o - 25oC (41o - 77oF) with brief excursions to 40oC (104oF). Avoid high humidity storage conditions.

USE DIRECTIONS:

Give amprolium at the 0.012% level (10 oz AMPROL 128 20% Soluble Powder 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 the sole source of amprolium.

SPL UNCLASSIFIED SECTION

MIXING AND DOSAGE ADMINISTRATION

PREMEASURED FOR AUTOMATIC
WATER PROPORTIONERS
For Automatic Water Proportioners

For use in automatic water proportioners that meter
1 fluid ounce of stock solution per gallon of drinking
water.

                                          Dissolve AMPROL 128
                                   (amprolium) 20% Soluble Powder
To prepare                       In one gallon of water
dosage levels of:       (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 (5oz) in 1 gallon

To Prepare 50 Gallons of Medicated Water

DOSAGE LEVEL           MIXING DIRECTIONS
0.024%                        Dissolve 8 ounces of AMPROL 128
                                   20% SOLUBLE POWDER in about 5
                                   gallons of water in a 50-gallon
                                   medicated barrel. Stir, then add
                                   water to the 50-gallon mark.
                                   Stir thoroughly.

0.012%                        Follow same directions as above but
                                   use 4 ounces of AMPROL 128 20%
                                   SOLUBLE POWDER.

0.006%                        Follow same directions as above but
                                   use 2 ounces of AMPROL 128 20%
                                   SOLUBLE POWDER.

SPL UNCLASSIFIED SECTION

Note: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a
clean, closed labeled container for up to 3 days.

AMPROL® is a registered trademark of Huvepharma.lnc.

PRINCIPAL DISPLAY PANEL - 283.5 grams Pouch Label

Amprol® 128
(amprolium)

20% Soluble Powder
Coccidiostat

Water-Soluble Treatment for Coccidiosis

Contents of each packet will treat

128 gallons at 0.012% level

Product # 970915

Net Contents: 10 oz. (283.5 grams)

Active Ingredient: amprolium...............20%

Distributed by:
Huvepharma, Inc.
Peachtree City, GA 30269
For questions, please call 1-877-4AMPROL
NADA 33-165, Approved by FDA

Huvepharma

INGREDIENTS AND APPEARANCE

AMPROL  128
amprolium powder

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 23243-9709
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)	AMPROLIUM	0.2 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-9709-3	24 in 1 PAIL
1		283.5 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA033165	06/06/2018

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

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