Amprol

Manufacturer
Huvepharma, Inc. | Huvepharma EOOD
Effective date
2024-10-31
Label type
OTC ANIMAL DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:43:48

Label at a glance#

ProductAmprol 128
Active ingredientAMPROLIUM
Label structure14 sections

Storage and handling

STORAGE: Store between 5º - 25ºC (41º - 77ºF) with brief excursions to 40ºC (104ºF). Avoid high humidity storage conditions.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

AMPROL® 128

(amprolium soluble powder)

20% Soluble Powder
Coccidiostat

Water-Soluble Treatment for Coccidiosis
Contents of each packet will treat
128 gallons at 0.012% level

OTC - ACTIVE INGREDIENT SECTION

Net Contents: 10 oz. (283.5 grams)
Active Ingredient: amprolium...........20%

SPL UNCLASSIFIED SECTION

Distributed by:
Huvepharma, Inc.
Peachtree City, GA 30269

For questions, please call 1-877-994-4883

Approved by FDA under NADA # 033-165

VETERINARY INDICATIONS SECTION

                     FOR ANIMAL USE ONLY

INDICATIONS FOR USE: AMPROL® 128 (amprolium soluble powder)
20% Soluble Powder is intended for the treatment of coccidiosis in growing
chickens, turkeys, and laying hens.

PRECAUTIONS SECTION

CAUTION: If no improvement is noted within 3 days, have the diagnosis reconfirmed 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.

RESIDUE WARNING SECTION

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

USER SAFETY WARNINGS SECTION

USER SAFETY WARNING: Not for Human Use. Keep out of reach of children.

STORAGE AND HANDLING SECTION

STORAGE: Store between 5º - 25ºC (41º - 77ºF) with brief excursions to 40ºC (104ºF). Avoid high
humidity storage conditions.

INDICATIONS & USAGE SECTION

USE DIRECTIONS: Give amprolium at the 0.012% level (10 oz AMPROL 128 20% Soluble Powder per
128 gallons) as soon as coccidiosis is diagnosed and continue for three to five 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.

Restricted Drug (California) – Use Only as Directed.

SPL UNCLASSIFIED SECTION

Lot No & Exp Date

Take TimeTake Time

DOSAGE & ADMINISTRATION SECTION

PREMEASURED FOR AUTOMATIC WATER PROPORTIONERS

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

      To prepare

   dosage levels of:

   Dissolve AMPROL 128

   (amprolium soluble powder) 20% Soluble Powder

   in one gallon of water.

   (Makes 1 gallon of stock solution.)

   0.024%

   2 bags (20 oz) in 1 gallon

   0.012%

   1 bag (10 oz) in 1 gallon

   0.006%

   ½ bag (5 oz) in 1 gallon

To Prepare 50 Gallons of Medicated Water

DOSAGE LEVEL

   MIXING DIRECTIONS

   0.024%

   Dissolve 8 ounces of AMPROL 128 20% Soluble Powder in about 5 gallons of water in a 50-gallon

   medicated barrel. Stir, then add water to the 50-gallon mark. Stir thoroughly.

   0.012%

   Follow same directions as above but use 4 ounces of AMPROL 128 20% Soluble Powder.

   0.006%

   Follow same directions as above but use 2 ounces of AMPROL 128 20% Soluble Powder.

SPL UNCLASSIFIED SECTION

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

ADVERSE REACTIONS SECTION

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 www.fda.gov/reportanimalae.

AMPROL® is a registered trademark of Huvepharma, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amprol 128 Film Rev. 09-2024Amprol 128 Film Rev. 09-2024

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092544amprolium 200 MG/ML Oral Solution [Amprol]SBD7
1006657amprolium 200 MG/ML Oral SolutionSCD7
1092544Amprol 128 20 % Oral SolutionSY7
1092544Amprol 200 MG/ML Oral SolutionSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-9709-3Amprol128283.5 g in 1 POUCHPOWDER283.57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23243-9709AMPROL 128 (AMPROLIUM) POWDER [HUVEPHARMA, INC.]71 package rows20241103_ccf7a5cc-b50a-4dc4-8de8-13c9e36608cb.zip

DailyMed Socrata Ingredients#

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

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
23243-970923243-9709-3

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 · Source PDF

Reported adverse events (FAERS/openFDA)#

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