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. |
Sections Modified
PRECAUTIONS
- Pediatric Use
- Dexedrine is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity...
MEDICATION GUIDE
- Who should not take Dexedrine?
- Dexedrine is not recommended for use in children less than 6 years old.
