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Name:Amprol 25
Manufacturer:Huvepharma, Inc.
Category:Animal Drugs


AMPROL 25%

AMPROL 25  - amprolium powder 
Huvepharma, Inc.

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AMPROL 25%

BAG FRONT

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)

Bag Back Panel

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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

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 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      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
0.0125%                                           1 lb
0.0175%                                           1 lb 61/2 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 exist
                                                    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 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 freed 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.

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AMPROL 25 
amprolium powder
Product Information
Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:23243-9561
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPROLIUM (AMPROLIUM) AMPROLIUM 250 g  in 1 kg
Product Characteristics
Color brown ((Light Tan to Brown)) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23243-9561-5 22.68 kg in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA012350 05/29/2009

Labeler - Huvepharma, Inc. (619153559)
Establishment
Name Address ID/FEI Operations
Huvepharma, Inc. 883128204 medicated animal feed manufacture, analysis, pack, label, manufacture

Revised: 05/2011 Huvepharma, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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