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Reference ID: 3416347 - Food and Drug Administration

HIGHLIGHTS OF PRESCRIBING INFORMATION Increase in Blood Pressure: Monitor blood pressure and pulse These highlights do not include all the information needed to at appropriate intervals. Use with caution in patients for use ADDERALL XR safely and effectively. See full whom blood pressure increases may be problematic. ( ). prescribing information for ADDERALL XR. Psychiatric Adverse Events: Stimulants may cause treatment- ADDERALL XR (mixed salts of a single-entity emergent psychotic or manic symptoms in patients with no amphetamine product) dextroamphetamine sulfate, prior history, or exacerbation of symptoms in patients with dextroamphetamine saccharate, amphetamine aspartate pre-existing psychosis.

of attention deficit hyperactivity disorder (ADHD). (1) Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14) Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14)

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