mydayis dextroamphetamine sulfate dextroamphetamine saccharate amphetamine aspartate monohydrate and amphetamine sulfate capsule extended release
1 INDICATIONS AND USAGE MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14) ] . MYDAYIS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. ( 1 ) Limitations of Use : Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite. ( 8.4 ) Limitations of Use : Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4) ] .
takeda pharmaceuticals america, inc.
CAPSULE BLUE Shire 465 50 mg
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mydayis dextroamphetamine sulfate dextroamphetamine saccharate amphetamine aspartate monohydrate and amphetamine sulfate capsule extended release
takeda pharmaceuticals america, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied MYDAYIS extended-release capsules are available as: 12.5 mg: green body/green cap (imprinted with black SHIRE 465 and 12.5 mg), bottles of 100, NDC 54092-468-01 25 mg: Ivory body/green cap (imprinted with black SHIRE 465 and 25 mg), bottles of 100, NDC 54092-471-01 37.5 mg: Ivory body/caramel cap (imprinted with black SHIRE 465 and 37.5 mg), bottles of 100, NDC 54092-474-01 50 mg: Ivory body/purple cap (imprinted with black SHIRE 465 and 50 mg), bottles of 100, NDC 54092-477-01 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
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