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Label Changes for:

Unisom SleepTabs (doxylamine succinate) Tablets, 25mg

September 2013

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

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


September 2013


  • added .....“Do not use in children under 12 years of age”