COCCIAID- amprolium solution

CocciAid by

Drug Labeling and Warnings

CocciAid by is a Animal medication manufactured, distributed, or labeled by Aurora Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

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.

SPL UNCLASSIFIED SECTION

Benzoic acid 0.1% added as preservative.

QUESTIONS

For questions, please call 888-215-1256.

DOSAGE & ADMINISTRATION

FOR ANIMAL USE ONLY
To Prepare 50 Gallons of Medicated Water

• DOSAGE LEVEL: MIXING 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 LEVEL: COCCIAID® 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.

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REORDER NO: 24001
Aurora Pharmaceutical, Inc.
NORTHFIELD, MN 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1465  06/2019

Container Label

PRINCIPAL DISPLAY PANEL - 1 gallon bottle label

INGREDIENTS AND APPEARANCE

COCCIAID 
amprolium solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51072-090
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)	AMPROLIUM	96   in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-090-00	3785 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200630	08/23/2018

Labeler - Aurora Pharmaceutical, Inc. (832848639)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Pharmaceutical, Inc.		832848639	manufacture