fluvoxamine maleate 25 mg
1 INDICATIONS AND USAGE Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-Compulsive Disorder Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults [see Clinical Studies (14) ] .
upsher-smith laboratories, llc
ROUND WHITE U 70
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16 HOW SUPPLIED/STORAGE AND HANDLING
FLUVOXAMINE MALEATE tablets, USP, for oral administration, are available as: 25 mg: off-white, round, biconvex, film-coated, debossed "U" over "70" on one side and plain on the other side. They are supplied as: Bottles of 100 with a child-resistant closure, NDC 0832-1670-11 50 mg: yellow, round, biconvex, film-coated, debossed "U" over "71" on one side and bisected on the other side. They are supplied as: Bottles of 100 with a child-resistant closure, NDC 0832-1671-11 100 mg: beige, round, biconvex, film-coated, debossed "U" over "672" on one side and bisected on the other side. They are supplied as: Bottles of 100 with a child-resistant closure, NDC 0832-1672-11
FLUVOXAMINE MALEATE tablets, USP should be protected from high humidity and stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep out of reach of children.
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