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Label Changes for:

Xyzal (levocetirizine dihydrochloride Oral Tabs)Xyzal (levocetirizine dihydrochloride Oral Solution)

June 2016

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

June 2016

ADVERSE REACTIONS

Post-Marketing Experience
  • Addition to listing of adverse reactions...arthralgia
  • Replacement of “events” with “reactions” throughout section.

 

November 2013

ADVERSE REACTIONS

Post-Marketing Experience
  • movement disorders (including dystonia and oculogyric crisis
  • tic, myoclonus, extrapyramidal symptoms

 

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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