lisdexamfetamine dimesylate 10 mg
1 INDICATIONS AND USAGE Lisdexamfetamine dimesylate capsules are 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 )] . 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 )] . Lisdexamfetamine dimesylate capsules are 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 lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions ( 5.2 )] . Lisdexamfetamine dimesylate capsules are 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 ) Lisdexamfetamine dimesylate capsules are 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 lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established. ( 5.2 )
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CAPSULE PINK M 5111 10mg
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LISDEXAMFETAMINE DIMESYLATE capsules:
LISDEXAMFETAMINE DIMESYLATE capsules 10 mg: Opaque pink Cap/Opaque pink Body, Hard Gelatin capsules, imprinted with black ink “10 mg†on the body and “M†in a box over “5111†on the cap Bottles of 100.................................................. NDC 0406-5111-01
LISDEXAMFETAMINE DIMESYLATE capsules 20 mg: Opaque yellow Cap/Opaque yellow Body, Hard Gelatin capsules, imprinted with black ink “20 mg†on the body and “M†in a box over “5112†on the cap Bottles of 100.................................................. NDC 0406-5112-01
LISDEXAMFETAMINE DIMESYLATE capsules 30 mg: Opaque orange Cap/Opaque white Body, Hard Gelatin capsules, imprinted with black ink “30 mg†on the body and “M†in a box over “5113†on the cap Bottles of 100.................................................. NDC 0406-5113-01
LISDEXAMFETAMINE DIMESYLATE capsules 40 mg: Opaque green Cap/Opaque white Body, Hard Gelatin capsules, imprinted with black ink “40 mg†on the body and “M†in a box over “5114†on the cap Bottles of 100.................................................. NDC 0406-5114-01
LISDEXAMFETAMINE DIMESYLATE capsules 50 mg: Opaque blue Cap/Opaque white Body, Hard Gelatin capsules, imprinted with black ink “50 mg†on the body and “M†in a box over “5115†on the cap Bottles of 100.................................................. NDC 0406-5115-01
LISDEXAMFETAMINE DIMESYLATE capsules 60 mg: Opaque blue Cap/Opaque blue Body, Hard Gelatin capsules, imprinted with black ink “60 mg†on the body and “M†in a box over “5116†on the cap Bottles of 100.................................................. NDC 0406-5116-01
LISDEXAMFETAMINE DIMESYLATE capsules 70 mg: Opaque orange Cap/Opaque blue Body, Hard Gelatin capsules, imprinted with black ink “70 mg†on the body and “M†in a box over “5117†on the cap Bottles of 100.................................................. NDC 0406-5117-01 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° to 86°F) [see USP Controlled Room Temperature] .
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