Animal NDC 23243-9561-5 Amprol 25 Type A Medicated Article
Amprolium

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-9561-5
Proprietary Name Amprol 25 Type A Medicated Article What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Amprolium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Huvepharma, Inc.
Product Type Otc Type A Medicated Article Animal Drug
Usage Information
    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 pheasantsand (2) development of active immunity to coccidiosis in replacement chickens.AMPROL 25% is also intended for use in the prevention and treatment ofcoccidiosis in laying chickens.
Active Ingredient(s)
  • Amprolium
Inactive Ingredient(s)
  • AMINO ACIDS, CORN GLUTEN (0540V8ZD7V)
  • SOYBEAN OIL (241ATL177A)
  • AMINO ACIDS, CORN GLUTEN (0540V8ZD7V)
  • SOYBEAN OIL (241ATL177A)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA012350 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Amprol 25 Type A Medicated Article Images

Amprol 25 Type A Medicated Article Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Bag Front



Approved by FDA under NADA # 012-350            Product 956150

AMPROL®25%
(amprolium)
Type A Medicated Article


Indications & Usage



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.


Warnings



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


Otc - Active Ingredient



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


Inactive Ingredient



INGREDIENTS: Corn Gluten Feed and Soybean Oil


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.

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)


Dosage & Administration



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.


General Precautions



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 Warnings



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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.