Label Changes for:

Xyzal (levocetirizine dihydrochloride) 5mg tablets and 2.5mg/5ml solution

September 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

September 2012

5 WARNINGS AND PRECAUTIONS

5.2 Urinary Retention
  • Urinary retention has been reported post-marketing....

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • added ..... urinary retention

17 PATIENT COUNSELING INFORMATION

 

 

March 2011 

 

ADVERSE REACTIONS

 Postmarketing Experience
  • vomiting, dysuria, blurred vision, angioedema, paraesthesia, dizziness

 

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