Amprol - Huvepharma, Inc | Huvepharma EOOD

Manufacturer
Huvepharma, Inc | Huvepharma EOOD
Effective date
2026-05-21
Label type
OTC ANIMAL DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:47:04

Label at a glance#

ProductAmprol
Active ingredientAMPROLIUM
Label structure12 sections

Storage and handling

STORAGE: Store between 5º - 25ºC (41º - 77ºF) with brief excursions to 40ºC. Note: When product is sitting for prolonged periods of time, black, brown, or orange to yellow particles may appear on the surface. Benzoic acid 0.1% added as preservative.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

AMPROL®

(amprolium oral solution)

9.6% Oral Solution                                          Lot No. and Exp. Date

Coccidiostat

Water-soluble treatment for coccidiosis         

Treats 800 Gallons at 0.012% level

Product # 09568A

Net Contents: 128 fl.oz (1 gal.) (3.785 L)

Active Ingredient: amprolium............9.6%

KCP-S00191 Rev. 03-2026

VETERINARY INDICATIONS SECTION

INDICATIONS FOR USE: AMPROL® (amprolium oral solution) 9.6% Oral Solution is intended for the
treatment of coccidiosis in growing chickens, turkeys, and laying hens. If no improvement is noted
within 3 days, have the diagnosis confirmed 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.

INSTRUCTIONS FOR USE SECTION

USE DIRECTIONS: Give amprolium at the 0.012% level (8 fl oz per 50 gallons) as soon as coccidiosis is
diagnosed and continue for 3 to 5 days. (In severe outbreaks, give amprolium at the 0.024% level.)
Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks. No other source of
drinking water should be available to the birds during this time. Use as the sole source of amprolium.
To disperse particles in the product, shake the bottle prior to each use.

RESIDUE WARNING SECTION

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

USER SAFETY WARNINGS SECTION

USER SAFETY WARNING: Keep this and all drugs out of the reach of children. NOT FOR HUMAN USE.

PRECAUTIONS SECTION

PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY.
MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention.
Restricted Drug (California) - Use Only as Directed.

STORAGE AND HANDLING SECTION

STORAGE: Store between 5º - 25ºC (41º - 77ºF) with brief excursions to 40ºC. Note: When product
is sitting for prolonged periods of time, black, brown, or orange to yellow particles may appear
on the surface.
Benzoic acid 0.1% added as preservative.

ADVERSE REACTIONS SECTION

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.

SPL UNCLASSIFIED SECTION

Distributed by:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269                                ®AMPROL is a registered
                                                                          trademark of Huvepharma, Inc.
Approved by FDA under NADA # 013-149

DOSAGE FORMS & STRENGTHS SECTION

               FOR ANIMAL USE ONLY

            To prepare 50 Gallons of Medicated Water

DOSAGE LEVELMIXING DIRECTIONS
0.024%Add 1 pint (16 fluid ounces) of AMPROL (amprolium oral solution) 9.6% Oral Solution to about 5 gallons of water in a 50-gallon medication barrel.  Stir, then add water to the 50-gallon mark. Stir thoroughly.
0.012%Follow same directions as above but use 1/2 pint (8 fluid ounces) of AMPROL 9.6% Oral Solution
0.006%Follow same directions as above but use 4 fluid ounces of AMPROL 9.6% Oral Solution

            For Automatic Water Proportioners
For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water.

DOSAGE LEVELAMPROL 9.6% ORAL SOLUTION PER
GALLON OF STOCK SOLUTION
0.024%
0.012%
0.006%
     41 fl oz
  20.5 fl oz
10.25 fl oz

Note: Make drinking water fresh daily. Stock solutions for proportioners may be stored
in a clean, closed labeled container for up to 3 days.

Take TimeTake Time

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amprol 1 gallon bottleAmprol 1 gallon bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amprol OS 1 Gal 06-2024.jpgAmprol OS 1 Gal 06-2024.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092546amprolium 9.6 % Oral SolutionPSN9
1092548amprolium 96 MG/ML Oral Solution [Amprol]SBD9
1092546amprolium 96 MG/ML Oral SolutionSCD9
1092548Amprol 9.6 % Oral SolutionSY9
1092548Amprol 96 MG/ML Oral SolutionSY9
1092546amprolium 9.6 % Oral SolutionSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-6681-2Amprol3785 mL in 1 BOTTLE, PLASTICSOLUTION37859
23243-6681-2Amprol4 in 1 BOXSOLUTION49

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMPROLIUMACTIVE INGREDIENT95CO6N199Q3
AMPROLIUMACTIVE MOIETY95CO6N199Q3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23243-668123243-6681-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
AMPROLIUM95CO6N199QACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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