R2 JANSSEN Pill — ORANGE OVAL, 12mm — Risperidone

R2 pill photo
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ImprintR2 / JANSSEN
ColourORANGE
ShapeOVAL
Size12
Strengthrisperidone 2 mg
Dosage formTablet
ManufacturerJanssen Pharmaceuticals, Inc.
NDC50458-320
Schedule—
AvailabilityPrescription only
Ingredientsrisperidone[risperidone]

What does this imprint mean?

The imprint "R2 JANSSEN" 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

Risperidone

Uses and warnings

BOXED WARNING: "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death." Risperidone is contraindicated in patients with known hypersensitivity to the product. Major warnings include increased cerebrovascular adverse events (including stroke) in elderly dementia patients, "Neuroleptic Malignant Syndrome," "tardive dyskinesia" (potentially irreversible), hyperglycemia and diabetes mellitus, hyperprolactinemia (with a theoretical risk related to breast cancer), orthostatic hypotension with syncope, and potential for cognitive/motor impairment.

Risperidone is indicated for: - "Acute and maintenance treatment of schizophrenia" in adults and adolescents 13-17 years - "Short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder" in adults and children/adolescents 10-17 years, alone or with lithium/valproate - "Treatment of irritability associated with autistic disorder," including aggression, self-injury, and tantrums, in children and adolescents aged 5-16 years

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file b192f7b6-639a-11ea-b722-633bfc2ca371.xml