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These highlights do not include all the information needed to use AMPHETAMINE EXTENDED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for AMPHETAMINE EXTENDED-RELEASE ORALLY DISINTEGRATING TABLETS. AMPHETAMINE extended-release orally disintegrating tablets, CII Initial U.S. Approval: 1960
Medication labelWhy this: Advisory · dailymed-prescription
Amphetamine extended-release orally disintegrating tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14)]. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)].
- generic_name
- amphetamine
- product_names
- Amphetamine
- ndc
- 0480-3315, 0480-3315-65, 0480-3316, 0480-3316-65, 0480-3317, 0480-3317-65, 0480-3318, 0480-3318-65, 0480-3319, 0480-3319-65, 0480-3320, 0480-3320-65
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en