MYLAN 5375 Pill — GREEN CAPSULE, 18mm — Doxepin

MYLAN pill photo
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ImprintMYLAN / 5375
ColourGREEN
ShapeCAPSULE
Size18
StrengthDOXEPIN HYDROCHLORIDE 75 mg
Dosage formCapsule
ManufacturerMylan Pharmaceuticals Inc.
NDC0378-5375
Schedule—
AvailabilityPrescription only
IngredientsDOXEPIN HYDROCHLORIDE[DOXEPIN]

What does this imprint mean?

The imprint "MYLAN 5375" 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

Doxepin

Uses and warnings

BOXED WARNING: "Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders," while "short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24"; "Doxepin is not approved for use in pediatric patients." Other key warnings cover monitoring for "clinical worsening, suicidality and unusual changes in behavior," angle-closure glaucoma risk from pupillary dilation, and caution with CYP2D6-inhibiting drugs.

Indicated for "psychoneurotic patients with depression and/or anxiety," depression and/or anxiety "associated with alcoholism," "associated with organic disease," and "psychotic depressive disorders with associated anxiety," targeting symptoms such as "anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry."

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file dd12459c-26cb-4ffd-b41f-654c1311589d.xml