Animal NDC 23243-9709-3 Amprol 128
Amprolium

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-9709-3
Proprietary Name Amprol 128 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 Animal Drug
Usage Information
                         FOR ANIMAL USE ONLYINDICATIONS FOR USE: AMPROL® 128 (amprolium)20% Soluble Powder is intended for the treatmentof coccidiosis in growing chickens, turkeys, andlaying hens.
Active Ingredient(s)
  • Amprolium
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 NADA033165 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 128 Images

Amprol 128 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



Other



AMPROL® 128

(amprolium)

20% Soluble Powder
Coccidiostat

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

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

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

Approved by FDA under NADA # 033-165

Lot No & Exp Date

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

AMPROL® is a registered trademark of Huvepharma, Inc.


Otc - Active Ingredient



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


Veterinary Indications



                     FOR ANIMAL USE ONLY

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


Precautions



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



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


User Safety Warnings



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


Storage And Handling



STORAGE: Store between 5° - 25°C (41° - 77°F) with brief excursions to 40°C (104°F). Avoid high
humidity storage conditions.


Indications & Usage



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.


Dosage & Administration



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) 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.


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