Sertraline 50 MG Oral Tablet

1 INDICATIONS AND USAGE Sertraline hydrochloride 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 is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)

Accord Healthcare, Inc.

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

8 months ago

ROUND WHITE S2

16 HOW SUPPLIED/STORAGE AND HANDLING

SERTRALINE HYDROCHLORIDE tablets, USP having functional scoring containing

SERTRALINE HYDROCHLORIDE equivalent to 25 mg, 50 mg and 100 mg of sertraline, are supplied as. 25 mg: light green to green colored, round, biconvex, film coated tablets, debossed with “S1” on one side and breakline on other side. NDC 16729-215-10 Bottles of 30’s count with child-resistant closure NDC 16729-215-11 Bottles of 50’s count with child-resistant closure NDC 16729-215-15 Bottles of 90’s count with child-resistant closure NDC 16729-215-43 Unit Dose Packages of 100’s count NDC 16729-215-16 Bottles of 500’s count 50 mg: light blue to blue colored, round, biconvex, film coated tablets, debossed with “S2” on one side and breakline on other side. NDC 16729-216-10 Bottles of 30’s count with child-resistant closure NDC 16729-216-15 Bottles of 90’s count with child-resistant closure NDC 16729-216-01 Bottles of 100’s count with child-resistant closure NDC 16729-216-16 Bottles of 500’s count with child-resistant closure NDC 16729-216-43 Unit Dose Packages of 100’s count 100 mg: yellow colored, round biconvex, film coated tablets, debossed with “S3” on one side and breakline on other side. NDC 16729-217-10 Bottles of 30’s count with child-resistant closure NDC 16729-217-15 Bottles of 90’s count with child-resistant closure NDC 16729-217-01 Bottles of 100’s count with child-resistant closure NDC 16729-217-16 Bottles of 500’s count with child-resistant closure NDC 16729-217-43 Unit Dose Packages of 100’s count Store

SERTRALINE HYDROCHLORIDE 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].

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