Vyvanse 30 MG Oral Capsule
1 INDICATIONS AND USAGE VYVANSE ® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1) ] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2) ] . VYVANSE is a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use : Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older ( 8.4 ) VYVANSE is not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established ( 5.2 ) Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4) ] . VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established [see Warnings and Precautions (5.2) ] .
Shire LLC
CAPSULE S489
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VYVANSE (
LISDEXAMFETAMINE DIMESYLATE ) capsules: VYVANSE capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg), bottles of 100, NDC 59417-101-10 VYVANSE capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg), bottles of 100, NDC 59417-102-10 VYVANSE capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg), bottles of 100, NDC 59417-103-10 VYVANSE capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg), bottles of 100, NDC 59417-104-10 VYVANSE capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg), bottles of 100, NDC 59417-105-10 VYVANSE capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg), bottles of 100, NDC 59417-106-10 VYVANSE capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg), bottles of 100, NDC 59417-107-10 VYVANSE (
LISDEXAMFETAMINE DIMESYLATE ) chewable tablets: VYVANSE chewable tablets 10 mg: white to off-white round shaped tablet debossed with '10' on one side and 'S489' on the other, bottles of 100, NDC 59417-115-01 VYVANSE chewable tablets 20 mg: white to off-white hexagonal shaped tablet debossed with '20' on one side and 'S489' on the other, bottles of 100, NDC 59417-116-01 VYVANSE chewable tablets 30 mg: white to off-white arc triangular shaped tablet debossed with '30' on one side and 'S489' on the other, bottles of 100, NDC 59417-117-01 VYVANSE chewable tablets 40 mg: white to off-white capsule shaped tablet debossed with '40' on one side and 'S489' on the other, bottles of 100, NDC 59417-118-01 VYVANSE chewable tablets 50 mg: white to off-white arc square shaped tablet debossed with '50' on one side and 'S489' on the other, bottles of 100, NDC 59417-119-01 VYVANSE chewable tablets 60 mg: white to off-white arc diamond shaped tablet debossed with '60' on one side and 'S489' on the other, bottles of 100, NDC 59417-120-01 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
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