escitalopram 5 MG Oral Tablet

1 INDICATIONS AND USAGE Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: Treatment of Major Depressive Disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of Generalized Anxiety Disorder (GAD) in adults ( 1 ) Escitalopram Tablets, USP are indicated for the treatment of: • Major Depressive Disorder (MDD) in adults and pediatric patients 12 years of age and older. • Generalized Anxiety Disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Exelan Pharmaceuticals Inc.

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

6 months ago

ROUND WHITE IG 249

6 months ago

IG 249 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

ESCITALOPRAM Tablets, USP 5 mg, 10 mg and 20 mg are supplied as follows: 5 mg Tablets: white, film coated, round, biconvex tablets debossed with IG on one side and 249 on other. Bottle of 30 NDC # 76282-249-30 Bottle of 90 NDC # 76282-249-90 Bottle of 100 NDC # 76282-249-01 Bottle of 500 NDC # 76282-249-05 Bottle of 1000 NDC # 76282-249-10 10 mg Tablets: white, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 250 on other. Bottle of 30 NDC # 76282-250-30 Bottle of 90 NDC # 76282-250-90 Bottle of 100 NDC # 76282-250-01 Bottle of 500 NDC # 76282-250-05 Bottle of 1000 NDC # 76282-250-10 20 mg Tablets: white, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 251 on other. Bottle of 30 NDC # 76282-251-30 Bottle of 90 NDC # 76282-251-90 Bottle of 100 NDC # 76282-251-01 Bottle of 500 NDC # 76282-251-05 Bottle of 1000 NDC # 76282-251-10 Storage and Handling Store at 20°C to 25°C (68° F to 77°F) excursions permitted to 15 to 30°C (59° to 86°F).

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