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Clinacox

Generic name: diclazuril powder
Dosage form: FOR ANIMAL USE ONLY

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Clinacox
(DICLAZURIL)

Anticoccidial
Type A Medicated Article

ACTIVE DRUG INGREDIENT: Diclazuril, 0.2%

INERT INGREDIENTS: Wheat middlings, calcium carbonate, soybean oil with 0.02% TBHQ (preservative), and silicon dioxide.

INDICATIONS: Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E necatrix, E.
acervulina, E brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective
against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a
short time after infection. Diclazuril was shown in studies to reduce lesion scores and
improve performance and health of birds challenged with E. maxima.

Growing turkeys: For the prevention of coccidosis caused by Eimeria adenoeides, E. gallopavonis, and
E. meleagrimitis.

IMPORTANT: MUST BE THOROUGHLY MIXED INTO POULTRY FEEDS BEFORE USE.

DIRECTIONS: Thoroughly mix one pound (1 Ib) of Clinacox (0.2% diclazuril) into each ton of complete feed to provide
1 ppm of diclazuril (use level). It is recommended that an intermediate mix containing one part
Clinacox Anticoccidial and not less than nine parts appropriate feed ingredient be thoroughly
mixed before incorporation into the final feed. The resulting Type C medicated feed should be fed
continuously as the sole ration.

WARNING: Not for use in hens producing eggs for human food.

CAUTION: Do not feed to breeding turkeys.

Diclazuril is a licensed product from Janssen Pharmaceutica, Beerse, Belgium
Clinacox is registered trademark of Johnson and Johnson, U.S. Patent:4,631,278.
Copyright 1998, 1999, 2001, Huvepharma, Inc. All rights reserved.

Net Wt 50 1b/22.68 kg

Store at or below 25°C (77 °F), excursions permitted to 40 °C (104 °F).

Huvepharma, Inc. 500 Westpark Drive, Suite 230 NADA #140-951, Approved by FDA.
Peachtree City, GA 30269

STORAGE CONDITIONS


Store at or below 25°C (77 °F), excursions permitted to 40 °C (104 °F).

Bag label Image

Bag label Image

Clinacox
diclazuril powder
Product Information
Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:23243-3010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLAZURIL (DICLAZURIL) DICLAZURIL 2 g in 1 kg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
SOYBEAN OIL
Packaging
# Item Code Package Description
1 NDC:23243-3010-5 22.68 kg in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140951 06/29/2009
Labeler - Huvepharma, Inc. (619153559)
Registrant - Huvepharma AD (552691651)
Establishment
Name Address ID/FEI Operations
Huvepharma, Inc. 619153559 manufacture, analysis, label, pack
Huvepharma, Inc.