mixed salts of a singleentity amphetamine product dextroamphetamine saccharate amphetamine aspartate monohydrate dextroamphetamine sulfate amphetamine sulfate capsule extended release
1 INDICATIONS AND USAGE Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies ( 14 )] . 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 )] . Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are 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 )
specgx llc
CAPSULE PINK M 37 5 mg
Related Pills
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Mixed Salts of a Single-Entity Amphetamine Product Extended-Release capsules are available as: Extended-release capsules 12.5 mg: opaque yellow body/opaque yellow cap (imprinted with "12.5 mg" and "M" in a box) Bottles of 100............................................................................................. NDC 0406-0805-01 Extended-release capsules 25 mg: opaque white body/opaque white cap (imprinted with "25 mg" and "M" in a box) Bottles of 100............................................................................................. NDC 0406-0803-01 Extended-release capsules 37.5 mg: opaque pink body/opaque blue cap (imprinted with "37.5 mg" and "M" in a box) Bottles of 100............................................................................................. NDC 0406-0807-01 Extended-release capsules 50 mg: opaque blue body/opaque blue cap (imprinted with "50 mg" and "M" in a box) Bottles of 100............................................................................................. NDC 0406-0804-01 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 to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
More pills like CAPSULE M 37 5 mg