AMPROL 25- amprolium powder

Amprol 25 by

Drug Labeling and Warnings

Amprol 25 by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc., Huvepharma EOOD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

For questions, call 1-877-4AMPROL

®AMPROL is a registered trademark of Huvepharma, Inc.

Net Wt.:   50 lb (22.68 kg)

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 In Type C Medicated Feeds:

  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%ampfolium 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 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.

STORAGE AND HANDLING

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

Amprol 25 Bag Label

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)	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	Marketing Start Date	Marketing End Date
1	NDC: 23243-9561-5	22.68 kg in 1 BAG

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

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

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