displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg clonazepam, a benzodiazepine. Each tablet also contains lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, purified water, and corn starch. Clonazepam tablets 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 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. It has the following structural formula:
C15H10ClN3O3 M.W. 315.72
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.
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
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Clonazepam tablets should be administered with water by swallowing the tablet whole.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Clonazepam tablets 0.5 mg are available as yellow, round, single-scored tablets debossed “832” above the scored line and “TEVA” on the unscored side.
Clonazepam tablets 1 mg are available as mottled green, round, single-scored tablets debossed “833” above the scored line and “TEVA” on the unscored side.
Clonazepam tablets 2 mg are available as white to off-white, round, single-scored tablets debossed “834” above the scored line and “TEVA” on the unscored side.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. P 9/2010
Image of Label
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4