Sarafem 10 MG Oral Tablet
1 INDICATIONS AND USAGE SARAFEM is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) ( 1.1 ) 1.1 Premenstrual Dysphoric Disorder (PMDD) SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD) [see Clinical Studies (14.1) ]. The effectiveness of SARAFEM in long-term use (that is, for more than 6 months) has not been systematically evaluated in placebo-controlled trials. The use of SARAFEM for extended periods should be periodically re-evaluated for the individual patient [see Dosage and Administration (2.1) ].
Warner Chilcott (US), LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SARAFEM ® (fluoxetine hydrochloride tablets) is available in 10 mg 1 , 15 mg 1 and 20 mg 1 strengths. The 10 mg tablet is a cream, round tablet embossed with S10 on one side: N DC 0430-0210-14 - Four blister cards of 7 tablets each The 15 mg tablet is a white, round tablet embossed with S15 on one side: N DC 0430-0215-14 - Four blister cards of 7 tablets each The 20 mg tablet is a yellow, round tablet embossed with S20 on one side: N DC 0430-0220-14 - Four blister cards of 7 tablets each 1 Equivalent to fluoxetine base. 16.2 Storage and Handling Store at 25˚ C (77˚ F); excursions permitted to 15˚ - 30˚ C (59˚ - 86˚ F) [see USP Controlled Room Temperature]
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