Risperidone 3 MG Oral Tablet
1 INDICATIONS AND USAGE Risperidone tablets are an atypical antipsychotic agent indicated for: Treatment of schizophrenia in adults and adolescent aged 13-17 years ( 1.1 ) Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescent aged 10-17 years ( 1.2 ) Treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years ( 1.3 ) 1.1 schizophrenia Adults Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1) ] . Adolescents Risperidone tablets are indicated for the treatment of schizophrenia in adolescents aged 13–17 years [see Clinical Studies (14.1) ]. 1.2 Bipolar Mania Monotherapy - Adults and Pediatrics Risperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2) ] . Combination Therapy – Adults The combination of risperidone tablets with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3) ] . 1.3 Irritability Associated with Autistic Disorder Pediatrics Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4) ] .
Breckenridge Pharmaceutical, Inc.
OVAL ORANGE RI5
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16 HOW SUPPLIED/STORAGE AND HANDLING 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 NDC 51991-316-06 Bottles of 100's NDC 51991-316-01 Bottles of 500's NDC 51991-316-05 Bottles of 1000's NDC 51991-316-10 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 NDC 51991-317-06 Bottles of 100's NDC 51991-317-01 Bottles of 500's NDC 51991-317-05 Bottles of 1000's NDC 51991-317-10 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 NDC 51991-318-06 Bottles of 100's NDC 51991-318-01 Bottles of 500's NDC 51991-318-05 Bottles of 1000's NDC 51991-318-10 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 NDC 51991-319-06 Bottles of 100's NDC 51991-319-01 Bottles of 500's NDC 51991-319-05 Bottles of 1000's NDC 51991-319-10 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 NDC 51991-320-06 Bottles of 100's NDC 51991-320-01 Bottles of 500's NDC 51991-320-05 Bottles of 1000's NDC 51991-320-10 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 NDC 51991-321-06 Bottles of 100's NDC 51991-321-01 Bottles of 1000's NDC 51991-321-10 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.
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5 years ago - Friday, Sep 20, 2019, 4:06 pm
Risperidone 3mg