AMPROL 25  - amprolium powder 
Huvepharma, Inc.

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AMPROL 25%

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NADA 12-350                                                            Product 956150
Approved by FDA

AMPROL 25%
(amprolium)
Type A Medicated Article

AMPROL (amprolium) 25% 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.

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

Ingredients: Corn Gluten Feed and Soybean Oil

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)

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WARNING

WARNING
Keep this and all drugs out of the reach of children.
The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain
an MSDS or for assistance, contact HUvepharma at 1-877-4AMPROL.

MIXING DIRECTIONS


MIXING DIRECTIONS

AMPROL (amprolium) 25% 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 0f 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 2S% 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      Use This Amount of
In Type C Medicated Feed       AMPROL 25% Per Ton
0.004 %                                           5 oz
0.006%                                            8 oz
0.008%                                           10 oz
0.0175%                                           1 lb
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%-0.00125%        5-8 weeks of age 0.004%-0.0125%
Over 8 week 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%-0.025% 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

CAUTION

Use as the sale 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.

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AMPROL 25 
amprolium   powder
Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)23243-9561
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMPROLIUM (AMPROLIUM) AMPROLIUM250 g  in 1 kg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Colorbrown ((Light Tan to Brown)) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
123243-9561-522.68 kg In 1 BAGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA01235005/29/2009

Labeler - Huvepharma, Inc. (619153559)
Establishment
NameAddressID/FEIOperations
Huvepharma, Inc.619153559manufacture, analysis, pack, label
Revised: 03/2011Huvepharma, Inc.