AMPROL 25 TYPE A MEDICATED ARTICLE- amprolium powder 
Huvepharma, Inc.

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AMPROL 25%

BAG FRONT

Approved by FDA under NADA # 012-350            Product 956150

AMPROL®25%
(amprolium)
Type A Medicated Article

INDICATIONS FOR USE: 

AMPROL® 25% (amprolium) Type A medicated article is intended for use in (1)
preventing outbreaks of coccidiosis in growing chickens, turkeys, and pheasants
and (2) development of active immunity to coccidiosis in replacement chickens.
AMPROL 25% is also intended for use in the prevention and treatment of
coccidiosis in laying chickens.

WITHDRAWAL PERIODS:
No withdrawal period is required when used according to labeling.

ACTIVE DRUG INGREDIENT: Amprolium. . . . . . 25%

INGREDIENTS: Corn Gluten Feed and Soybean Oil

STORAGE: Store at or below 25°C (77°F), excursions permitted to 40°C (104°F).
Avoid prolonged exposure to high humidity.

SEE DIRECTIONS ON BACK PANEL

Manufactured by:                                              Huvepharma, Inc.
Huvepharma, Inc., St. Louis, MO 63116          525 Westpark Drive, Suite 230
                                                                          Peachtree City, GA 30269

Distributed by:
Huvepharma, Inc., Peachtree City, GA 30269

®AMPROL is a registered trademark of Huvepharma, Inc.

Net Wt.: 50 lb (22.68 kg)

Take Time

MIXING DIRECTIONS
AMPROL® 25% (amprolium) Type A Medicated Article should be thoroughly and evenly mixed in the feed. AMPROL 25% may be used
to manufacture a Type C medicated feed in the concentration range of 0.004% to 0.025%. The table below shows the amount of
AMPROL 25% to be used in each ton (2000 lb) of feed to obtain desired levels of amprolium in the Type C medicated feed.

To aid in even distribution of AMPROL 25% in the finished feed, prepare a mixture of AMPROL 25% in a portion of complete feed
ingredient before mixing into the finished ration. Blend the mixture with the remainder of the finished feed and mix thoroughly.

  Feeding level of Amprolium

in Type C Medicated Feed

     Use This Amount of

AMPROL 25% Per Ton

0.004%

5 oz.

0.006%

8 oz

0.008%

10 oz

0.0125%

1 lb

0.0175%

1 lb 6 ½ oz

0.025%

2 lb

AMOUNT AND DIRECTIONS FOR USE

CHICKENS

 Broilers:

 Prevention:

 Use 0.0125% amprolium Type C medicated feed continuously for most field conditions as they exist under   modern management practices. Where severe coccidiosis conditions exists and where immunity is not   required, use 0.025% amprolium Type C medicated feed. For field conditions where only E. tenella is the   major problem, use 0.008%-0.0125% amprolium Type C medicated feed.

 Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found   to be resistant to Amprolium.

 Replacements:

 Immunity   Development or   Prevention

 Prevention   Program:

 Where immunity development is not desirable, use 0.0125%-0.025% amprolium Type C medicated feed   continuously from day old until onset of production.

 Immunity   Development

 Program:

 Use 0.004%-0.0125% amprolium Type C medicated feed continuously until onset

 of production.

Selection of the level to be used should be based upon comparative hazard of infection with cecal and intestinal species. The higher
levels will interfere with the development of immunity to E. tenella (cecal).
The following are suggested feeding schedules for various conditions of coccidial exposure. The planning and evaluation of any
program should be in the hands of a veterinarian or poultry pathologist who is familiar with the specific operation and with the
general nature of disease problems in the area.

 1. Severe exposure

 2. Moderate exposure

 3. Slight exposure

 0-5 weeks of age 0.0125%

 0-5 weeks of age 0.008%-0.0125%

 0-5 weeks of age 0.004%-0.0125%

 5-8 weeks of age 0.008%-0.0125%

 5-8 weeks of age 0.006%-0.0125%

 5-8 weeks of age 0.004%-0.0125%

 over 8 weeks of age 0.004%-0.0125%

 over 8 weeks of age 0.004%-0.0125%

 over 8 weeks of age 0.004%-0.0125%

 LAYING   CHICKENS:

 Treatment:

 Use 0.025% amprolium Type C medicated feed for two weeks in severe outbreaks or

 0.0125% amprolium Type C medicated feed for two weeks in moderate outbreaks.

 Prevention:

 Use 0.0125% amprolium Type C medicated feed continuously.

 TURKEYS:

 Prevention:

 Use 0.0125%-0.025% amprolium Type C medicated feed continuously.

 PHEASANTS:

 For the prevention of coccidiosis in growing pheasants caused by Eimeria colchici, E. duodenalis, and E.   phasiani.

Type C medicated feed with 0.0175% amprolium should be fed continuously as the sole ration.

CAUTION

Use as the sole source of amprolium.

Do not change the litter while giving this feed unless absolutely necessary.
If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis, 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.
In replacement flocks the grower must expect that excessive exposure to one or more species may overwhelm the drug in some flocks and prompt treatment will be required.
Fertility, hatchability and other reproductive data are not available on amprolium in breeding pheasants.
Do not use in feeds containing bentonite.
Restricted Drug (California) - Use Only as Directed.

USER SAFETY WARNING
Not for human use. Keep out of reach of children.
Contact Huvepharma Inc. at 1-877-994-4883 or http://www.huvepharma.us. For additional information about reporting side effects for
animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Amprol 25 Bag Label

Amprol Bag Label

AMPROL 25  TYPE A MEDICATED ARTICLE
amprolium powder
Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:23243-9561
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM250 g  in 1 kg
Inactive Ingredients
Ingredient NameStrength
AMINO ACIDS, CORN GLUTEN (UNII: 0540V8ZD7V)  
SOYBEAN OIL (UNII: 241ATL177A)  
Product Characteristics
Colorbrown ((Light Tan to Brown)) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23243-9561-522.68 kg in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA01235005/29/2009
Labeler - Huvepharma, Inc. (619153559)
Registrant - Huvepharma EOOD (552691651)
Establishment
NameAddressID/FEIBusiness Operations
Huvepharma, Inc.883128204medicated animal feed manufacture, analysis, pack, label, manufacture

Revised: 12/2022
Document Id: 780d387a-e022-4e60-b394-8010d69d507e
Set id: 5c136c27-8955-41e4-beef-d94fdafae418
Version: 8
Effective Time: 20221221
 
Huvepharma, Inc.