RISPERIDONE
These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993
ea914046-6cc2-4c7b-b12b-76c31bb18def
HUMAN PRESCRIPTION DRUG LABEL
Nov 10, 2010
WOCKHARDT LIMITED
DUNS: 650069115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
RISPERIDONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
BOXED WARNING SECTION
BOXED WARNING
CONTRAINDICATIONS SECTION
4CONTRAINDICATIONS
Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone. Therefore, risperidone is contraindicated in patients with a known hypersensitivity to the product.
- Known hypersensitivity to the product (4)
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
Boxed Warning 08/2008
Warnings and Precautions (5.1) 08/2008
Warnings and Precautions, Leucopenia, Neutropenia, and Agranulocytosis (5.8)
09/2009
Boxed Warning 08/2008
Warnings and Precautions (5.1) 08/2008
Warnings and Precautions, Leucopenia, Neutropenia, and Agranulocytosis (5.8)
09/2009
DOSAGE FORMS & STRENGTHS SECTION
3DOSAGE FORMS AND STRENGTHS
Risperidone Oral Solution is available in 1 mg/mL strength.
- Oral solution: 1 mg/mL (3)