Label: RISPERIDONE tablet, film coated

  • NDC Code(s): 69367-368-05, 69367-368-60, 69367-369-05, 69367-369-60, view more
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 6, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1)]

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  • 1 INDICATIONS AND USAGE
    1.1 Schizophrenia - Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to ...
  • 2 DOSAGE AND ADMINISTRATION
    Table 1. Recommended Daily Dosage by Indication - Initial DoseTitration - (Increments)Target DoseEffective Dose Range - Schizophrenia: adults (2.1)2 mg1 to 2 mg4 to 8 mg4 to 16 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Risperidone Tablets, USP 0.25 mg: Dark yellow, film-coated, capsule-shaped, convex tablet, debossed "R1" on one side and "R" on the other side. Risperidone Tablets, USP 0.5 mg: Reddish brown ...
  • 4 CONTRAINDICATIONS
    Risperidone is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone formulation. Hypersensitivity ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis - Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of ...
  • 6 ADVERSE REACTIONS
    The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Pharmacokinetic-related Interactions - The dose of risperidone should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme inducers ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Risperidone is not a controlled substance. 9.2 Abuse - Risperidone has not been systematically studied in animals or humans for its potential for abuse. While the ...
  • 10 OVERDOSAGE
    10.1 Human Experience - Premarketing experience included eight reports of acute risperidone overdosage with estimated doses ranging from 20 to 300 mg and no fatalities. In general, reported signs ...
  • 11 DESCRIPTION
    Risperidone Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Risperidone was administered in the diet at doses of 0.63, 2.5, and 10 mg/kg for 18 months to mice and for 25 ...
  • 14 CLINICAL STUDIES
    14.1 Schizophrenia - Adults - Short-Term Efficacy - The efficacy of risperidone in the treatment of schizophrenia was established in four short-term (4- to 8-week) controlled trials of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Risperidone Tablets, USP 0.25 mg are available as dark yellow, film-coated, capsule-shaped, convex tablet, debossed "R1" on one side and "R" on the other side, packaged as ...
  • 17 PATIENT COUNSELING INFORMATION
    Physicians are advised to discuss the following issues with patients for whom they prescribe risperidone. Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Renata Limited (General Plant-2) Noyapara, Bhawal Mirzapur - Rajendrapur, Gazipur, 1700 - Bangladesh - Distributed by: Westminster Pharmaceuticals, LLC - Nashville, TN 37217 - Rev ...
  • PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label
    NDC 69367-368-05 - Rx Only - risperiDONE - Tablets, USP - 0.25 mg - 500 Tablets - Westminster - Pharmaceuticals
  • PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label
    NDC 69367-369-05 - Rx Only - risperiDONE - Tablets, USP - 0.5 mg - 500 Tablets - Westminster - Pharmaceuticals
  • PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
    NDC 69367-370-05 - Rx Only - risperiDONE - Tablets, USP - 1 mg - 500 Tablets - Westminster - Pharmaceuticals
  • PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label
    NDC 69367-371-05 - Rx Only - risperiDONE - Tablets, USP - 2 mg - 500 Tablets - Westminster - Pharmaceuticals
  • PRINCIPAL DISPLAY PANEL - 3 mg Tablet Bottle Label
    NDC 69367-372-05 - Rx Only - risperiDONE - Tablets, USP - 3 mg - 500 Tablets - Westminster - Pharmaceuticals
  • PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label
    NDC 69367-373-05 - Rx Only - risperiDONE - Tablets, USP - 4 mg - 500 Tablets - Westminster - Pharmaceuticals
  • INGREDIENTS AND APPEARANCE
    Product Information