CLONAZEPAM TABLETS, USP                                CIV, 40-8804, Revised — June 2009, Rx Only

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Clonazepam a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder insoluble in water, sparingly soluble in acetone and chloroform and slightly soluble in alcohol. It has a molecular weight of 315.72 and the following structural formula:

CONTRAINDICATIONS

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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow angle glaucoma.

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.

DOSAGE AND ADMINISTRATION

id: 44a69dbe-b4ea-467f-b51b-7a6dad3b949b
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Clonazepam tablets should be administered with water by swallowing the tablet whole.

HOW SUPPLIED

id: 749f85ae-78cb-44cf-8516-d4376b850864
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Clonazepam Tablets, USP are available as follows: 0.5 mg — Each pink, round tablet imprinted and 33 on one side and scored on the other side contains 0.5 mg of clonazepam USP. Tablets are supplied in blisters of 30 (NDC 67046-915-30). 1 mg — Each yellow, round tablet imprinted and 34 on one side and scored on the other side contains 1 mg of clonazepam USP. Tablets are supplied in blisters of 30 (NDC 67046-917-30). 2 mg — Each white, round tablet imprinted and 35 on one side and scored on the other side contains 2 mg of clonazepam USP. Tablets are supplied in blisters of 30 (NDC 67046-919-30). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 07207 USA 40-8804 Revised — June 2009 Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA Original–07/2010–NJW

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

id: fc7d1137-417a-4ae6-b0cf-f0abd2a6f1fc
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

id: b5c39942-92c9-4293-9c57-36381a368056
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4