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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) ] . 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 ) 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) ] .
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CAPSULE YELLOW M 12 5 mg
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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, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] . Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Mixed Salts of a Single-Entity Amphetamine Product Extended-Release capsules by a medicine take-back program. Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Mixed Salts of a Single-Entity Amphetamine Product Extended-Release capsules at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Mixed Salts of a Single-Entity Amphetamine Product Extended-Release capsules with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Mixed Salts of a Single-Entity Amphetamine Product Extended-Release capsules in the household trash.
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