Animal NDC 61133-8290-1 Ampromed-p For Poultry

Amprolium

Animal NDC Product Code 61133-8290-1

Field Name Field Value
Animal NDC Code 61133-8290-1
Proprietary Name Ampromed-p For Poultry 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 Bimeda Inc.
Product Type Otc Animal Drug
Active Ingredient(s)
  • Amprolium
Marketing Category ANADA - ABBREVIATED 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 ANADA200496 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.

Ampromed-p For Poultry Animal Product Label Images

Ampromed-p For Poultry 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

Dosage & Administration

AmproMed™- P FOR POULTRY (amprolium)       9.6% Oral SolutionCoccidiostatWater soluble treatment for coccidiosis Treats 800 Gallons at 0.012% level.Restricted Drug (California) – Use Only as DirectedANADA 200-496, Approved by FDANet Contents:1Gallon (128 fl oz) (3.785 L)ACTIVE INGREDIENT: amprolium..............9.6%FOR ANIMAL USE ONLYTo prepare 50 Gallon of Medicated Water DOSAGE LEVEL MIXING DIRECTIONS0.024 %Add 1 pint (16 fluid ounces) of AmproMed™ P FOR POULTRY 9.6% Oral Solution in 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 AmproMed™ P FOR POULTRY 9.6% Oral Solution.0.006 %Follow same directions as above but use 4 fluid ounces of AmproMed™ P FOR POULTRY 9.6% Oral Solution.PREMEASURED FOR AUTOMATIC WATER PROPORTIONERS:For use in automatic water proportioners that meter 1 fluid ounce of stock solution for per gallon of drinking water.TO PREPARE DOSAGE LEVELS OFAmproMed™ P FOR POULTRY 9.6 % Oral Solution                   PER GALLON OF STOCK SOLUTION 0.024 % 41 fl oz 0.012 % 20.5 fl oz 0.006 % 10.25 fl ozNOTE: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.Benzoic acid as Sodium Benzoate 0.1% added as preservative.

Storage And Handling

STORAGE: Store container in an upright position. Store between 5°C - 25°C (41°F - 77°F) with brief excursions to 40°C.                To obtain an MSDS or for asistance contact Bimeda, Inc., at 1-888-524-6332.

Indications & Usage

INDICATIONS: AmproMed™ P FOR POULTRY 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 (8fl oz AmproMed™ P FOR POULTRY 9.6% Oral Solution per 50 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.

Warnings

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

Precautions

PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITAION. For irritation, flush with pleanty of water; get medical attention.

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

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