sertraline 25 mg

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 hydrochloride tablets are 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)

Aurobindo Pharma Limited

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

3 years ago

OVAL GREEN A 1 6

16 HOW SUPPLIED/STORAGE AND HANDLING

SERTRALINE HYDROCHLORIDE Tablets USP, 25 mg are green colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘6’ on the other side. NDC 65862-011-30 Bottles of 30 NDC 65862-011-50 Bottles of 50 NDC 65862-011-60 Bottles of 60 NDC 65862-011-90 Bottles of 90 NDC 65862-011-01 Bottles of 100 NDC 65862-011-05 Bottles of 500 NDC 65862-011-99 Bottles of 1,000 NDC 65862-011-51 Bottles of 5,000

SERTRALINE HYDROCHLORIDE Tablets USP, 50 mg are blue colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘7’ on the other side. NDC 65862-012-30 Bottles of 30 NDC 65862-012-50 Bottles of 50 NDC 65862-012-60 Bottles of 60 NDC 65862-012-90 Bottles of 90 NDC 65862-012-01 Bottles of 100 NDC 65862-012-05 Bottles of 500 NDC 65862-012-99 Bottles of 1,000 NDC 65862-012-51 Bottles of 5,000

SERTRALINE HYDROCHLORIDE Tablets USP, 100 mg are yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side. NDC 65862-013-30 Bottles of 30 NDC 65862-013-50 Bottles of 50 NDC 65862-013-60 Bottles of 60 NDC 65862-013-90 Bottles of 90 NDC 65862-013-01 Bottles of 100 NDC 65862-013-05 Bottles of 500 NDC 65862-013-99 Bottles of 1,000 NDC 65862-013-25 Bottles of 2,500 Store

SERTRALINE HYDROCHLORIDE Tablets USP at 20º to 25 ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [See USP Controlled Room Temperature].

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