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