ZOAMIX- dinitolmide powder

Drug Labeling and Warnings

Drug Details [pdf]

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Zoamix®

Zoalene
Type A Medicated Article
Coccidiostat

Net Wt 50LB (22.68 kg)

 

Ingredients

Active drug ingredient
Zoalene (3,5-dinitro-o-toluamide)	25%

Inactive ingredients
Roughage product, ground limestone, mineral oil	75%

INDICATIONS & USAGE

For use in preparation of feeds for chickens and turkeys only.

Livestock remedy.

Indications for Use

Broiler Chickens: For prevention and control of coccidiosis

Replacement Chickens: For development of active immunity to coccidiosis

Growing Turkeys: For prevention and control of coccidiosis

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It is suggested that a mixture of Zoamix and some feed ingredient be prepared prior to mixing in with the finished ration. This will ensure thorough and even
distribution in the feed.

Directions

It is suggested that a mixture of Zoamix and some feed ingredient be prepared prior to mixing in with the finished ration. This will ensure thorough and even distribution in the feed.

Broiler Chickens

For broiler chickens:
Use 1 lb (454 g) of Zoamix per 2,000 lb (909 kg) of finished product to produce a feed containing 0.0125% zoalene. Zoamix should be thoroughly blended into the
finished feed. Feed containing zoalene should be fed continuously as the only ration from the time chicks are placed in floor pens until they are slaughtered for meat.

Replacement chickens:

For replacement chickens:
Feed containing zoalene can be used in a program to raise replacement birds. When used under conditions of exposure to coccidiosis, it will allow immunity to
develop adequately to protect against losses due to the disease when the birds are placed on nonmedicated feed for egg laying purposes. The following chart
outlines the type of feeding program to follow where complete formulated feed is the sole ration:

	Starter ration			Grower ration*
Growing condition	% Zoalene per ton	Zoamix to be added per ton of feed		% Zoalene in feed	Zoamix to be added per ton of feed
		(lb)	(g)		(lb)	(g)
Severe exposure to coccidiosis expected	0.0125	1	454	0.0083 to 0.0125	2/3 to 1	303 to 454
Light to moderate exposure to coccidiosis expected	0.0083 to 0.0125	2/3 to 1	303 to 454	0.004 to 0.0083	1/3 to 2/3	151 to 303

 * Grower ration not to be fed to birds over 14 weeks of age.

For Growing Turkeys

For Growing Turkeys:
When turkey poults are reared in confinement and severe exposure to coccidiosis is usually a problem, use 1½ lb (681 g) of Zoamix per ton (2,000 lb)
of feed to produce a finished feed containing 0.0187% zoalene. Under the usual conditions of rearing turkey poults, or when turkey poults are on range, use 1 lb
(454 g) of Zoamix per 2,000 lbs (909 kg) of feed to produce a finished feed containing 0.0125% zoalene. The feed containing zoalene should be fed
continuously until the birds are 14 to 16 weeks of age.

Combinations with other drugs

Use only in accordance with the current New Animal Drug Regulation for zoalene, Section 558.680 of the Regulations promulgated under the Federal Food, Drug and
Cosmetic Act.

Cautions

Not to be fed to laying birds.
Consult a veterinarian or poultry pathologist if losses exceed 0.5% in a two-day period.
Avoid inhaling dust.
Avoid contact with eyes.

WITHDRAWAL PERIODS

No withdrawal period is required when used according to labeling.

Storage Conditions

Store below 37°C

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Restricted Drug (California) - use only as directed. Not for human use.
Approved by FDA under NADA # 011-116

Questions/Comments? For technical assistance or to obtain a Safety Data Sheet(s), contact Phibro Animal Health
Corporation at 888-403-0074 or http://www.pahc.com. To report side effects, contact Phibro Animal Health Corporation
at 1-888-475-7355. For additional information about reporting side effects, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae
Phibro, Phibro logo and Zoamix are trademarks owned by or licensed to Phibro Animal Health Corporation or its affiliates.

Distributed by:

Phibro Animal Health Corporation

Teaneck, NJ 07666

Net Wt 50 LB (22.68 kg)

176-9032-02

PRINCIPAL DISPLAY PANEL - 22.68 kg Bag

Zoamix Label

INGREDIENTS AND APPEARANCE

ZOAMIX 
dinitolmide powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-1116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DINITOLMIDE (UNII: AOX68RY4TV) (DINITOLMIDE - UNII:AOX68RY4TV)	DINITOLMIDE	5.67 kg  in 22.68 kg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-1116-1	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA011116	05/04/1960

Labeler - Phibro Animal Health (006989008)