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These highlights do not include all the information needed to use FLUOXETINE TABLETS safely and effectively. See full prescribing information for FLUOXETINE TABLETS. FLUOXETINE tablets, for oral use Initial U.S. Approval:1987
Medication labelWhy this: Advisory · dailymed-prescription
Fluoxetine tablets, USP are indicated for the treatment of premenstrual dysphoric disorder (PMDD) [see Clinical Studies (14.1)]. The effectiveness of fluoxetine tablets, USP in long-term use (that is, for more than 6 months) has not been systematically evaluated in placebo-controlled trials. The use of fluoxetine tablets, USP for extended periods should be periodically re-evaluated for the individual patient [ see Dosage and Administration (2.1)].
- generic_name
- fluoxetine
- product_names
- Fluoxetine
- ndc
- 13668-443, 13668-473, 13668-443-74, 13668-443-10, 13668-443-01, 13668-443-30, 13668-443-91, 13668-473-10, 13668-473-74, 13668-473-30, 13668-473-01, 13668-473-91
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en