MYLAN 4220 Pill — TURQUOISE;PINK CAPSULE, 16mm — Fluoxetine

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ImprintMYLAN / 4220
ColourTURQUOISE;PINK
ShapeCAPSULE
Size16
StrengthFLUOXETINE HYDROCHLORIDE 20 mg
Dosage formCapsule
ManufacturerCardinal Health
NDC55154-5495
Schedule—
Availability—
IngredientsFLUOXETINE HYDROCHLORIDE[FLUOXETINE]

What does this imprint mean?

The imprint "MYLAN 4220" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Fluoxetine

Uses and warnings

BOXED WARNING: BOXED WARNING - Suicidal Thoughts and Behaviors: "Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies." Monitoring is required for all ages starting antidepressant therapy. "Fluoxetine is not approved for use in children less than 7 years of age." Key Warnings Include: - Serotonin syndrome risk when combined with other serotonergic drugs - Allergic reactions and rash (discontinue if occurs) - Activation of mania/hypomania in bipolar patients - Seizure risk in predisposed individuals - Weight loss and appetite changes - Abnormal bleeding (especially with NSAIDs/warfarin) - Angle-closure glaucoma in susceptible patients - Hyponatremia/SIADH - QT interval prolongation - Cognitive and motor impairment potential --- | BOXED WARNING - Suicidal Thoughts and Behaviors: "Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies." Monitoring is required for all ages starting antidepressant therapy. "Fluoxetine is not approved for use in children less than 7 years of age." Key Warnings Include: - Serotonin syndrome risk when combined with other serotonergic drugs - Allergic reactions and rash (discontinue if occurs) - Activation of mania/hypomania in bipolar patients - Seizure risk in predisposed individuals - Weight loss and appetite changes - Abnormal bleeding (especially with NSAIDs/warfarin) - Angle-closure glauc

Fluoxetine is indicated for: - "Acute and maintenance treatment of Major Depressive Disorder" - "Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)" - "Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa" - "Acute treatment of Panic Disorder, with or without agoraphobia" ---

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file a7dc3e65-a424-45c4-aeff-01b4c5f24a8c.xml