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Animal NDC 51072-090-00 Cocciaid

Amprolium

Animal Product Information

Field Name Field Value
Animal NDC Code 51072-090-00
Proprietary Name Cocciaid 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 Aurora Pharmaceutical, Inc.
Product Type Otc Animal Drug
Usage Information
    CocciAid® (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
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • WATER (059QF0KO0R)
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 ANADA200630 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.

Cocciaid Images

Cocciaid 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.

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NDC 51072-090-00

CocciAid®

(amprolium)

9.6% Oral Solution

Coccidiostat

Water-soluble treatment for coccidiosis

Treats 800 gallons at 0.012% level

Approved by FDA under ANADA # 200-630

Net Contents:

1 Gallon (128 fl oz) (3.785 L)

Benzoic acid 0.1% added as preservative.

REORDER NO: 24001
Aurora Pharmaceutical, Inc.
NORTHFIELD, MN 55057
1-888-215-1256
www.aurorapharmaceutical.com
IN 50-1465  10/2020


Active Ingredient:



amprolium.........9.6%


Indications:



CocciAid® (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 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:



Store between 5°–25°C (41°–77°F) with brief excursions to 40°C.


Otc - Questions



For questions, please call 1-888-215-1256.


Dosage & Administration



FOR ANIMAL USE ONLY
To Prepare 50 Gallons of Medicated Water

DOSAGE LEVELMIXING DIRECTIONS
0.024%Add 1 pint (16 fluid ounces) of CocciAid​® (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 CocciAid​® 9.6% Oral Solution.
0.006%Follow same directions as above but use 4 fluid ounces of CocciAid​® 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 LEVELCOCCIAID® 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.


Container Label



PRINCIPAL DISPLAY PANEL - 1 gallon bottle label


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