sertraline sertraline tablet film coated

1 INDICATIONS AND USAGE Sertraline tablets are 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 tablets are 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)

Exelan Pharmaceuticals, Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] nausea` `[5] headache` `[6] off label use` `[7] diarrhoea` `[8] dyspnoea` `[9] vomiting` `[10] arthralgia`

4 weeks ago

OVAL BLUE I G 213

4 weeks ago

I G 213 OVAL BLUE

16 HOW SUPPLIED/STORAGE AND HANDLING

SERTRALINE 25 mg Tablets: Light green film coated Modified oval biconvex tablets debossed with I on the left Side of bisect and G on the right Side of bisect on one Side and “212” on other NDC 76282-212-30 Bottles of 30 NDC 76282-212-60 Bottles of 60 NDC 76282-212-90 Bottles of 90 NDC 76282-212-01 Bottles of 100 NDC 76282-212-18 Bottles of 180 NDC 76282-212-05 Bottles of 500

SERTRALINE 50 mg Tablets: Light blue film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “213” on other NDC 76282-213-30 Bottles of 30 NDC 76282-213-60 Bottles of 60 NDC 76282-213-90 Bottles of 90 NDC 76282-213-01 Bottles of 100 NDC 76282-213-18 Bottles of 180 NDC 76282-213-05 Bottles of 500

SERTRALINE 100 mg Tablets: Light yellow film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “214” on other NDC 76282-214-30 Bottles of 30 NDC 76282-214-60 Bottles of 60 NDC 76282-214-90 Bottles of 90 NDC 76282-214-01 Bottles of 100 NDC 76282-214-18 Bottles of 180 NDC 76282-214-05 Bottles of 500 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

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