Amprol 25

Manufacturer
Huvepharma, Inc. | Huvepharma EOOD
Effective date
2025-10-13
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:46:03

Label at a glance#

ProductAmprol 25 Type A Medicated Article
Active ingredientAMPROLIUM
Label structure11 sections

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. St. Louis, MO 63116 Huvepharma, Inc. 525 Westpark Drive, Suite 230 Peachtree City, GA 30269 Distributed by: HUVEPHARMA, INC. Peachtree City, GA 30269 For questions please call 1-877-994-4883 ®AMPROL is a registered trademark of Huvep...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 012-350            Product 956150

AMPROL® 25%
(amprolium)
Type A Medicated Article

INDICATIONS & USAGE SECTION

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.

RESIDUE WARNING SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

INGREDIENTS: Corn Gluten Feed and Soybean Oil

STORAGE AND HANDLING SECTION

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. St. Louis, MO 63116

Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

Distributed by:
HUVEPHARMA, INC. Peachtree City, GA 30269

For questions please call 1-877-994-4883

®AMPROL is a registered trademark of Huvepharma, Inc.

Net Wt.: 50 lb (22.68 kg)

SPL UNCLASSIFIED SECTION

Take TimeTake Time

DOSAGE & ADMINISTRATION SECTION

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. duoden ali s,

 and E. phasiani .

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

GENERAL PRECAUTIONS SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amprol Bag LabelAmprol Bag Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-9561-5Amprol 25Type A Medicated Article22.68 kg in 1 BAGPOWDER22.6810

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMPROLIUMACTIVE INGREDIENT95CO6N199Q6
AMPROLIUM IONACTIVE MOIETYH2T307KMZR6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23243-956123243-9561-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-05-03full-release2026-06-01 02:43:04

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.