Risperidone 0.5 MG Oral Tablet
1 INDICATIONS AND USAGE Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 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 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ] . 1.2 Bipolar Mania Monotherapy Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2) ] . Adjunctive Therapy Risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3) ] . 1.3 Irritability Associated with Autistic Disorder Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4) ] .
Ajanta Pharma Limited
ROUND ORANGE RI2
RI2 ROUND ORANGE
Related Pills
Risperidone 0.5 MG Oral Tablet
Ajanta Pharma Limited
Risperidone 0.5 MG Oral Tablet
Ajanta Pharma Limited
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
RISPERIDONE Tablets
RISPERIDONE Tablets, USP 0.25 mg are orange, circular, biconvex, film-coated tablets, engraved with 'RI1' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-002-06 Bottles of 500's NDC 27241-002-50
RISPERIDONE Tablets, USP 0.5 mg are orange, circular, biconvex, film-coated tablets, engraved with 'RI2' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-003-06 Bottles of 500's NDC 27241-003-50
RISPERIDONE Tablets, USP 1 mg are white to off white, circular, biconvex, film-coated tablets, engraved with 'RI3' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-001-06 Bottles of 500's NDC 27241-001-50
RISPERIDONE Tablets, USP 2 mg are yellow, circular, biconvex film-coated tablets, engraved with 'RI4' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-004-06 Bottles of 500's NDC 27241-004-50
RISPERIDONE Tablets, USP 3 mg are orange, capsule shaped, biconvex film-coated tablets, engraved with 'RI5' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-005-06 Bottles of 500's NDC 27241-005-50
RISPERIDONE Tablets, USP 4 mg are brown, ovaloid, biconvex, film-coated tablets, engraved with 'RI6' on one side and plain on other and are supplied as follows: Bottles of 60’s with child-resistant closure NDC 27241-006-06 Bottles of 500's NDC 27241-006-50 16.2 Storage and Handling
RISPERIDONE tablets should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Protect from light and moisture. Keep out of reach of children.
More pills like ROUND RI2