Clinacox

Dosage Form: FOR ANIMAL USE ONLY
Clinacox

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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 NDC Product Code (Source) 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23243-3010-5 22.68 kg In 1 BAG None

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

Revised: 03/2010Huvepharma, Inc.