risperidone 0.25 mg
1 INDICATIONS AND USAGE Risperidone is 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 is 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 is 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 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 is 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 )] .
Zydus Pharmaceuticals (USA) Inc.
ROUND YELLOW Z 4
Z 4 ROUND YELLOW
Related Pills
risperidone 0.25 mg
Zydus Pharmaceuticals (USA) Inc.
Risperidone 2 mg
Zydus Pharmaceuticals (USA) Inc.
risperidone 1 mg
zydus pharmaceuticals (usa) inc.
aripiprazole 15 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 USP, 0.25 mg are dark yellow, round, biconvex film-coated tablets debossed with "Z" on one side and "4" on the other side and are supplied as follows: NDC 68382-112-06in bottle of 30 tablets with child-resistant closure NDC 68382-112-14 in bottle of 60 tablets with child-resistant closure NDC 68382-112-16 in bottle of 90 tablets with child-resistant closure NDC 68382-112-01 in bottle of 100 tablets NDC 68382-112-05 in bottle of 500 tablets NDC 68382-112-10 in bottle of 1000 tablets
RISPERIDONE Tablets USP, 0.5 mg are red-brown colored, round, biconvex film-coated tablets debossed with "Z" on one side and "6" on other side and are supplied as follows: NDC 68382-113-06 in bottle of 30 tablets with child-resistant closure NDC 68382-113-14 in bottle of 60 tablets with child-resistant closure NDC 68382-113-16 in bottle of 90 tablets with child-resistant closure NDC 68382-113-01 in bottle of 100 tablets NDC 68382-113-05 in bottle of 500 tablets NDC 68382-113-10 in bottle of 1000 tablets
RISPERIDONE Tablets USP, 1 mg are white to off-white, round, biconvex film-coated tablets debossed with "ZC 75" on one side and plain on other side and are supplied as follows: NDC 68382-114-06 in bottle of 30 tablets with child-resistant closure NDC 68382-114-14 in bottle of 60 tablets with child-resistant closure NDC 68382-114-16 in bottle of 90 tablets with child-resistant closure NDC 68382-114-01 in bottle of 100 tablets NDC 68382-114-05 in bottle of 500 tablets NDC 68382-114-10 in bottle of 1000 tablets
RISPERIDONE Tablets USP, 2 mg are orange, round, biconvex film-coated tablets debossed with "ZC 76" on one side and plain on other side and are supplied as follows: NDC 68382-115-06 in bottle of 30 tablets with child-resistant closure NDC 68382-115-14 in bottle of 60 tablets with child-resistant closure NDC 68382-115-16 in bottle of 90 tablets with child-resistant closure NDC 68382-115-01 in bottle of 100 tablets NDC 68382-115-05 in bottle of 500 tablets NDC 68382-115-10 in bottle of 1000 tablets
RISPERIDONE Tablets USP, 3 mg are yellow, round, biconvex film-coated tablets debossed with "ZC 77"on one side and plain on other side and are supplied as follows: NDC 68382-116-06 in bottle of 30 tablets with child-resistant closure NDC 68382-116-14 in bottle of 60 tablets with child-resistant closure NDC 68382-116-16 in bottle of 90 tablets with child-resistant closure NDC 68382-116-01 in bottle of 100 tablets NDC 68382-116-05 in bottle of 500 tablets NDC 68382-116-10 in bottle of 1000 tablets
RISPERIDONE Tablets USP, 4 mg are green, round, biconvex film-coated tablets debossed with "ZC 78" on one side and plain on other side and are supplied as follows: NDC 68382-117-06 in bottle of 30 tablets with child-resistant closure NDC 68382-117-14 in bottle of 60 tablets with child-resistant closure NDC 68382-117-16 in bottle of 90 tablets with child-resistant closure NDC 68382-117-01 in bottle of 100 tablets NDC 68382-117-05 in bottle of 500 tablets NDC 68382-117-10 in bottle of 1000 tablets 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep out of reach of children. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
More pills like ROUND Z 4