paroxetine 12.5 mg
1 INDICATIONS AND USAGE Paroxetine extended-release tablets are indicated in adults for the treatment of: • Major depressive disorder (MDD) • panic disorder (PD) • Social Anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Paroxetine extended-release tablets are selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): • Major depressive Disorder (MDD) • panic disorder (PD) • Social Anxiety Disorder (SAD) • Premenstrual Dysphoric Disorder (PMDD)
Cadila Pharmaceuticals Limited
ROUND YELLOW X1
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16 HOW SUPPLIED/STORAGE AND HANDLING
PAROXETINE extended-release tablets are supplied as follows:
PAROXETINE extended-release tablets 12.5 mg are yellow, biconvex, enteric film-coated, extended- release, round tablets, debossed with “X1” on one side and plain on the other side. The tablets should be free from all physical defects. NDC 71209-094-01 Bottle of 30’s NDC 71209-094-10 Bottle of 500’s
PAROXETINE extended-release tablets 25 mg are pink, biconvex, enteric film-coated, extended- release, round tablets debossed with "X2" on one side and plain on the other side. The tablets should be free from all physical defects. NDC 71209-095-01 Bottle of 30’s NDC 71209-095-10 Bottle of 500’s
PAROXETINE extended-release tablets 37.5 mg are blue, biconvex, enteric film-coated, extended- release, round tablets debossed with "X3" on one side and plain on the other side. The tablets should be free from all physical defects. NDC 71209-096-01 Bottle of 30’s NDC 71209-096-10 Bottle of 500’s Store at or below 20°C to 25°C (68°F to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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