fluvoxamine maleate tablet film coated
1 INDICATIONS AND USAGE Fluvoxamine maleate tablets, USP 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, USP 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, USP 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] ).
ROUND YELLOW E 15
E 15 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluvoxamine Maleate Tablets, USP, for oral administration, are available as 25 mg off-white, round, biconvex, film-coated, debossed “ E ” over “17” on one side and plain on the other side and supplied as: NDC 0185-0017-01 bottles of 100 50 mg yellow, round, biconvex, film-coated, debossed “ E ” over “27” on one side and bisected on the other side and supplied as: NDC 0185-0027-01 bottles of 100 NDC 0185-0027-05 bottles of 500 100 mg beige, round, biconvex, film-coated, debossed “ E ” over “157” on one side and bisected on the other side and supplied as: NDC 0185-0157-01 bottles of 100 NDC 0185-0157-05 bottles of 500 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. PROTECT FROM LIGHT. PROTECT FROM HIGH HUMIDITY. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
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