M P5 Pill — ORANGE ROUND, 8mm — Paroxetine

M pill photo
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ImprintM / P5
ColourORANGE
ShapeROUND
Size8
StrengthPAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg
Dosage formTablet, Film Coated, Extended Release
ManufacturerMylan Pharmaceuticals Inc.
NDC0378-2005
Schedule—
Availability—
IngredientsPAROXETINE HYDROCHLORIDE HEMIHYDRATE[PAROXETINE]

What does this imprint mean?

The imprint "M P5" 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

Paroxetine

Uses and warnings

BOXED WARNING: "Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients" in short-term studies; patients should be monitored closely, especially when starting therapy or changing doses. Contraindicated with MAOIs and with thioridazine or pimozide, and in patients with known hypersensitivity. Other key warnings cover serotonin syndrome with other serotonergic drugs, "can cause fetal harm when administered to a pregnant woman," increased risk of bleeding events with antiplatelet/anticoagulant drugs, activation of mania/hypomania, and a discontinuation syndrome if stopped abruptly.

Paroxetine tablets are indicated in adults for: - Major depressive disorder (MDD) - Obsessive compulsive disorder (OCD) - Panic disorder (PD) - Social anxiety disorder (SAD) - Generalized anxiety disorder (GAD) - Posttraumatic stress disorder (PTSD). The label states "paroxetine tablets, USP is not approved for use in pediatric patients."

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 4556ee7a-81a3-4616-be05-8af3057252d7.xml