fluvoxamine maleate tablet coated
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 8-17), and one maintenance trial in adults [see Clinical Studies ( 14 )] .
ani pharmaceuticals, inc.
OVAL YELLOW 12 25
12 25 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
FLUVOXAMINE MALEATE Tablets USP are available in the following strengths, colors, imprints, and presentations: Tablets 25 mg: unscored, white, elliptical, film-coated (debossed “1222” on one side) Bottles of 100 ……………………………………………………NDC 62559-158-01 Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other) Bottles of 100 ……………………………………………………NDC 62559-159-01 Tablets 100 mg: scored, beige, elliptical, film-coated (debossed “1221” on one side and scored on the other) Bottles of 100 ……………………………………………………NDC 62559-160-01 Keep out of reach of children.
FLUVOXAMINE MALEATE Tablets 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 in tight containers.
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