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Animal NDC 23243-6681-2 Amprol

Amprolium

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-6681-2
Proprietary Name Amprol 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
    INDICATIONS FOR USE: AMPROL® (amprolium) 9.6% Oral Solution is intended for the treatment ofcoccidiosis 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 cancontribute to the virulence of coccidiosis under field conditions.
Active Ingredient(s)
  • Amprolium
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • WATER (059QF0KO0R)
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 NADA013149 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 Images

Amprol 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



Front Panel



AMPROL®

(amprolium)

9.6% Oral Solution

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%

1022-1814-03 Rev. 09-2022


Veterinary Indications



INDICATIONS FOR USE: AMPROL® (amprolium) 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



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.


Residue Warning



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


User Safety Warnings



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


Precautions



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



STORAGE: Store between 5° - 25°C (41° - 77°F) with brief excursions to 40°C.
Benzoic acid 0.1% added as preservative.


Adverse Reactions



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.


Other



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


Dosage Forms & Strengths



               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) 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.

See bottle for Lot No.
and Exp. Date


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