• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

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.


Note: This page links to PDF files which require the free Adobe Acrobat Reader4.

Adderall (mixed salts of a single entity amphetamine product) TabletsMedication Guide 5Label6
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release CapsulesMedication Guide7Label8
Concerta (methylphenidate hydrochloride) Extended-Release TabletsMedication GuideLabel9
Daytrana (methylphenidate) Transdermal SystemMedication GuideLabel10
Desoxyn (methamphetamine hydrochloride) TabletsMedication GuideLabel 11
Dexedrine (dextroamphetamine sulfate) Spansule Capsules and TabletsMedication GuideLabel12
Focalin (dexmethylphenidate hydrochloride) TabletsMedication GuideLabel13
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release CapsulesMedication GuideLabel14
Metadate CD (methylphenidate hydrochloride) Extended-Release CapsulesMedication GuideLabel15
Methylin (methylphenidate hydrochloride) Oral SolutionMedication Guide16Label17
Methylin (methylphenidate hydrochloride) Chewable TabletsMedication Guide18Label19
Ritalin (methylphenidate hydrochloride) TabletsMedication Guide20Label21
Ritalin SR (methylphenidate hydrochloride) Sustained-Release TabletsMedication Guide22Label23
Ritalin LA (methylphenidate hydrochloride) Extended-Release CapsulesMedication Guide24Label25
Strattera (atomoxetine hydrochloride) CapsulesMedication Guide26Label27