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

Amprolium

Animal Product Information

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
Usage Information
    AmproMed™ P FOR POULTRY (amprolium)      9.6% Oral Solution CoccidiostatWater-soluble treatment for coccidiosisTreats 800 Gallons at 0.012% level.Restricted Drug (California) – Use Only as DirectedApproved by FDA under ANADA # 200-496Net Contents:1 Gallon (128 fl oz) (3.785 L)Active Ingredient: amprolium..............9.6%INDICATIONS: AmproMed P FOR POULTRY (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.
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 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.

Table of Contents



Indications & Usage



AmproMed™ P FOR POULTRY 

(amprolium)      

9.6% Oral Solution Coccidiostat

Water-soluble treatment for coccidiosis

Treats 800 Gallons at 0.012% level.

Restricted Drug (California) – Use Only as Directed

Approved by FDA under ANADA # 200-496

Net Contents:

1 Gallon (128 fl oz) (3.785 L)

Active Ingredient: amprolium..............9.6%

INDICATIONS: AmproMed P FOR POULTRY (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.


Dosage & Administration



USE DIRECTIONS: Give amprolium at the 0.012% level (8 fl oz 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.

FOR ANIMAL USE ONLY

To prepare 50 Gallons of Medicated Water

DOSAGE LEVEL

MIXING DIRECTIONS

0.024 %

Add 1 pint (16 fluid ounces) of AmproMed P FOR POULTRY (amprolium) 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.

For Automatic Water Portioners

For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water.

DOSAGE LEVEL

AmproMed 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 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.


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 plenty of water; get medical attention.


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.

Benzoic acid as Sodium Benzoate 0.1% added as preservative.

The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the SDS contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.


Other



Manufactured by:

Bimeda, Inc.

Le Sueur, MN 56058


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