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
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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.
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