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Label Changes for:

Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules

May 2008

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View

Sections Modified


  • Pediatric Use
    • Dexedrine is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity...


  • Who should not take Dexedrine?
    • Dexedrine is not recommended for use in children less than 6 years old.