FDA Label for Clonazepam
View Indications, Usage & Precautions
Clonazepam Product Label
The following document was submitted to the FDA by the labeler of this product St Marys Medical Park Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Contraindications
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
The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.
Dosage And Administration
Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.
How Supplied
Clonazepam tablets USP 1 mg are blue, round, flat faced, beveled edge, debossed with “C 1” on one side and plain on the other. They are supplied as follows:
NDC: 60760-300-30 bottle of 30
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
India.
10 7744 1 626035
Issued October, 2010.
Clonazepam
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