brexpiprazole 1 MG Oral Tablet Rexulti
1 INDICATIONS AND USAGE REXULTI is indicated for: Adjunctive treatment of major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3) ] . REXULTI is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults and pediatric patients ages 13 years and older ( 1 , 14.2 ) Treatment of agitation associated with dementia due to Alzheimer's disease ( 1 , 14.3 ) Limitations of Use : REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease ( 1 )
otsuka america pharmaceutical, inc.
ROUND YELLOW BRX 1
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied REXULTI (
BREXPIPRAZOLE) tablets have markings on one side and are available in the following strengths and package configurations (see below): 0.25 mg tablets are light brown, round, shallow convex, bevel-edged body with "BRX" and "0.25" imprinted on one side NDC 59148-035-13 Bottles of 30 0.5 mg tablets: are light orange, round, shallow convex, bevel-edged body with "BRX" and "0.5" imprinted on one side NDC 59148-036-13 Bottles of 30 1 mg tablets are light yellow, round, shallow convex, bevel-edged body with "BRX" and "1" imprinted on one side NDC 59148-037-13 Bottles of 30 2 mg tablets are light green, round, shallow convex, bevel-edged body with "BRX" and "2" imprinted on one side NDC 59148-038-13 Bottles of 30 3 mg tablets are light purple, round, shallow convex, bevel-edged body with "BRX" and "3" imprinted on one side NDC 59148-039-13 Bottles of 30 4 mg tablets are white, round, shallow convex, bevel-edged body with "BRX" and "4" imprinted on one side NDC 59148-040-13 Bottles of 30 Storage Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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