The following Structured Product Label (SPL) was submitted to the FDA by St Marys Medical Park Pharmacy for the product Clonazepam (NDC 60760-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding contraindications, adverse reactions, dosage and administration, how supplied, clonazepam, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.
Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.
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.
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