fluoxetine 20 MG as fluoxetine hydrochloride 22.4 MG Oral Capsule
1 INDICATIONS AND USAGE Fluoxetine Capsules USP are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies ( 14.1 )] . • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies ( 14.2 )]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies ( 14.3 )] . • Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies ( 14.4 )]. Fluoxetine Capsules USP and Olanzapine in Combination are indicated for the treatment of: • Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine Capsules USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor indicated for: • Acute and maintenance treatment of Major Depressive Disorder (MDD) ( 1 ) • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) ( 1 ) • Acute and maintenance treatment of Bulimia Nervosa ( 1 ) • Acute treatment of Panic Disorder, with or without agoraphobia ( 1 ) Fluoxetine Capsules USP and olanzapine in combination for treatment of: • Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 )
Teva Pharmaceuticals USA Inc
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine capsules USP, 40 mg are available as white to off-white, powder-filled light blue opaque hard gelatin capsules, radial spin printed “ ” and “4346” on the cap and “40 mg” on the body in black ink, containing fluoxetine hydrochloride, USP equivalent to 40 mg fluoxetine packaged in bottles of 30 capsules. NDC 0093- 4346 -56 40 mg packaged in bottles of 30 capsules company logo 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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