1 INDICATIONS AND USAGE Sertraline hydrochloride is indicated for the treatment of the following [See Clinical Studies (14) ] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Post-traumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
16 HOW SUPPLIED/STORAGE AND HANDLING
SERTRALINE HYDROCHLORIDE 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg" NDC 59762-6347-1 Bottles of 30
SERTRALINE HYDROCHLORIDE 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg" NDC 59762-6443-1 Bottles of 30 NDC 59762-6443-2 Bottles of 100 NDC 59762-6443-3 Bottles of 500
SERTRALINE HYDROCHLORIDE 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "100 mg" NDC 59762-5160-1 Bottles of 30 NDC 59762-5160-2 Bottles of 100 NDC 59762-5160-3 Bottles of 500
SERTRALINE HYDROCHLORIDE oral solution: clear, colorless solution with a menthol scent containing
SERTRALINE HYDROCHLORIDE equivalent to 20 mg of sertraline per mL and 12% alcohol NDC 59762-0067-1 Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks. Store
SERTRALINE HYDROCHLORIDE at 20Â°C to 25Â°C (68Â°F to 77Â°F); excursions permitted to 15Â°C to 30Â°C (59Â°F to 86Â°F) [See USP Controlled Room Temperature].
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