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U.S. Department of Health and Human Services

Drugs

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FDA Asks Attention-Deficit Hyperactivity Disorder (ADHD) Drug Manufacturers to Develop Patient Medication Guides

FDA has directed the manufacturers of all drug products approved for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) to develop patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

Drugs

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Adderall (mixed salts of a single entity amphetamine product) TabletsMedication Guide Label
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release CapsulesMedication GuideLabel
Concerta (methylphenidate hydrochloride) Extended-Release TabletsMedication GuideLabel
Daytrana (methylphenidate) Transdermal SystemMedication GuideLabel
Desoxyn (methamphetamine hydrochloride) TabletsMedication GuideLabel
Dexedrine (dextroamphetamine sulfate) Spansule Capsules and TabletsMedication GuideLabel
Focalin (dexmethylphenidate hydrochloride) TabletsMedication GuideLabel
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release CapsulesMedication GuideLabel
Metadate CD (methylphenidate hydrochloride) Extended-Release CapsulesMedication GuideLabel
Methylin (methylphenidate hydrochloride) Oral SolutionMedication GuideLabel
Methylin (methylphenidate hydrochloride) Chewable TabletsMedication GuideLabel
Ritalin (methylphenidate hydrochloride) TabletsMedication GuideLabel
Ritalin SR (methylphenidate hydrochloride) Sustained-Release TabletsMedication GuideLabel
Ritalin LA (methylphenidate hydrochloride) Extended-Release CapsulesMedication GuideLabel
Strattera (atomoxetine hydrochloride) CapsulesMedication GuideLabel