Animal NDC 23243-6681-1 Amprol

Amprolium

Animal NDC Product Code 23243-6681-1

Field Name Field Value
Animal NDC Code 23243-6681-1
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
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 Animal Product Label 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.

Product Labeling Index

Front Panel

AMPROL®(amprolium)9.6% Oral SolutionCoccidiostatWater-soluble treatment for coccidiosisTreats 100 Gallons at 0.012% levelProduct # 66819Net Contents: 16 fl.oz (473 mL)Active Ingredient: Amprolium............9.6%Distributed by:Huvepharma, Inc.525 Westpark Drive, Suite 230Peachtree City, GA 30269                HUVEPHARMA

Indications

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.

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

Warning:

Keep this and all drugs out of the reach of children. NOT FOR HUMAN USE.

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 50 - 250C (410 - 770F) with brief excursions to 400C.Benzoic acid 0.1% added as preservative.For questions, please call 1-877-4AMPROLNADA 013-149Approved by FDA                        Lot No and Exp. Date

Dosage And Mixing Directions

FOR ANIMAL USE ONLYTo prepare 50 Gallons of Medicated WaterDOSAGE LEVELMIXING DIRECTIONS0.024%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 addwater to the 50-gallon mark. Stir thoroughly.0.012%Follow same directions as above but use 1/2 pint (8 fluid ounces) ofAMPROL 9.6% Oral Solution0.006%Follow same directions as above but use 4 fluid ounces of AMPROL 9.6%Oral SolutionFor Automatic Water ProportionersFor automatic water proportioners that meter 1 fluid ounceof stock solution per gallon of drinking water.DOSAGE LEVELAMPROL 9.6% ORAL SOLUTION PERGALLON OF STOCK SOLUTION0.024%0.012%0.006%41 fl oz20.5 fl oz10.25 fl ozNote: Make drinking water fresh daily. Stock solutions for proportioners may be storedin a clean, closed labeled container for up to 3 days

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

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