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fluoxetine 10 mg

1 INDICATIONS AND USAGE Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients age 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) 1.1 Major Depressive Disorder Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1) ]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1) ]. 1.2 Obsessive Compulsive Disorder Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ]. The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2) ]. 1.3 Bulimia Nervosa Fluoxetine is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3) ]. The physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3) ]. 1.4 Panic Disorder Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4) ]. The effectiveness of fluoxetine in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)].

ScieGen Pharmaceuticals, Inc


2 years ago OVAL WHITE S G 420 fluoxetine 10 mg

OVAL WHITE S G 420

2 years ago OVAL WHITE S G 420 fluoxetine 10 mg

S G 420 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

FLUOXETINE Tablets, USP are available containing

FLUOXETINE hydrochloride, USP equivalent to 10 mg or 20 mg of

FLUOXETINE.

FLUOXETINE Tablets, USP 10 mg are white to off white, oval shape film coated, functional-scored tablets debossed with "SG' on scored side and "420" on other side. Bottles of 30 NDC 50228-420-30 Bottles of 100 NDC 50228-420-01 Bottles of 1000 NDC 50228-420-10

FLUOXETINE Tablets USP, 20 mg are white to off white, oval shape film coated, functional-scored tablets debossed with "SG' on scored side and "421" on other side. Bottles of 30 NDC 50228-421-30 Bottles of 100 NDC 50228-421-01 Bottles of 1000 NDC 50228-421-10 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.


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