Label Changes for:

Aleve-D Sinus & Cold and Aleve-D Sinus & Headache (naproxen sodium, 220 mg and pseudoephedrine HCl, 120 mg) extended-release tablets

April 2009

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

Label approved 04/17/2009 is not available on Drugs@FDA

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

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. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

DIRECTIONS

WARNINGS

  • Revised cardiovascular warning from
    • "When using this product long term
      continuous use may increase the risk of heart attack or stroke”
    • to “When using this product the risk of heart attack or stroke may increase if you use more than directed or for longer than directed”
  • Addition of the warning statement
    • "Ask a doctor before use if you have asthma"
    • “Do not use in children under 12 years of age”

DIRECTIONS

  • children under 12 years: "do not use"
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