MYLAN 214 Pill — ORANGE ROUND, 8mm — Haloperidol

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ImprintMYLAN / 214
ColourORANGE
ShapeROUND
Size8
StrengthHALOPERIDOL 2 mg
Dosage formTablet
ManufacturerA-S Medication Solutions
NDC50090-4400
Schedule—
Availability—
IngredientsHALOPERIDOL[HALOPERIDOL]

What does this imprint mean?

The imprint "MYLAN 214" 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

Haloperidol

Uses and warnings

BOXED WARNING: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death; drug-treated patients had "a risk of death between 1.6 to 1.7 times the risk of death in placebo-treated patients," mostly from cardiovascular or infectious causes. "Haloperidol is not approved for the treatment of patients with dementia-related psychosis." Other key warnings: contraindicated in severe CNS depression, comatose states, and Parkinson's disease; risk of QT-interval prolongation and Torsade de Pointes, sometimes fatal; tardive dyskinesia, a potentially irreversible movement disorder; and Neuroleptic Malignant Syndrome, a potentially fatal symptom complex.

Indicated for "management of the manifestations of psychotic disorders," for "the control of tics and vocal utterances of Tourette's Disorder" in children and adults, for treatment of severe behavior problems in children marked by combativeness and explosive hyperexcitability, and short-term treatment of hyperactive children with "excessive motor activity with accompanying conduct disorders."

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file eb8d14cf-6853-4549-bb7d-6f7b998e6f30.xml