oxcarbazepine 300 MG Oral Tablet
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 is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years (1)
Sun Pharmaceutical Industries Limited
OVAL YELLOW 1 84
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oxcarbazepine tablet film coated
sun pharmaceutical industries, inc.
oxcarbazepine 300 MG Oral Tablet
Sun Pharmaceutical Industries Limited
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16 HOW SUPPLIED/STORAGE AND HANDLING 150 mg film-coated Tablets: yellow color, capsule-shaped, biconvex, coated tablets scored and debossed with ‘183’ on one side and scored on other side. Bottle of 30: Child Resistant Cap NDC 62756-183-83 Bottle of 100: Child Resistant Cap NDC 62756-183-88 Bottle of 100: NDC 62756-183-08 Bottle of 500: NDC 62756-183-13 Bottle of 1000: NDC 62756-183-18 300 mg film-coated Tablets: yellow color, capsule-shaped, biconvex, coated tablets scored and debossed with ‘184’ on one side and scored on other side. Bottle of 30: Child Resistant Cap NDC 62756-184-83 Bottle of 100: Child Resistant Cap NDC 62756-184-88 Bottle of 100: NDC 62756-184-08 Bottle of 500: NDC 62756-184-13 Bottle of 1000: NDC 62756-184-18 600 mg film-coated Tablets: yellow color, capsule-shaped, biconvex, coated tablets scored and debossed with ‘185’ on one side and scored on other side. Bottle of 30: Child Resistant Cap NDC 62756-185-83 Bottle of 100: Child Resistant Cap NDC 62756-185-88 Bottle of 100: NDC 62756-185-08 Bottle of 500: NDC 62756-185-13 Bottle of 1000: NDC 62756-185-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).
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