oxcarbazepine 300 mg
1 INDICATIONS AND USAGE Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets are indicated for: • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: o Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years o Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )
Glenmark Pharmaceuticals Inc., USA
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16 HOW SUPPLIED/STORAGE AND HANDLING 150 mg film-coated Tablets: yellow, film-coated oval, biconvex tablets with a deep break line on both sides and "G" engraved on one side of the deep break line on one side of the tablet and "13" and "7" engraved on either side of the deep break line on the other side of the tablet. Bottle of 100.........NDC 68462-137-01 Bottle of 500.........NDC 68462-137-05 300 mg film-coated Tablets: yellow, film-coated oval, biconvex tablets with a deep break line on both sides and "G" and "4" engraved on either side of the deep break line on one side of the tablet. Bottle of 100.........NDC 68462-138-01 Bottle of 500.........NDC 68462-138-05 600 mg film-coated Tablets: yellow, film-coated oval, biconvex tablets with a deep break line on both sides and "G" engraved on one side of the deep break line on one side of the tablet and "13" and "9" engraved on either side of the deep break line on the other side of the tablet. Bottle of 100.........NDC 68462-139-01 Bottle of 500.........NDC 68462-139-05 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).
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