Label Changes for:
Xyzal (levocetirizine dihydrochloride) 5mg tablets and 2.5mg/5ml solution
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)
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
- vomiting, dysuria, blurred vision, angioedema, paraesthesia, dizziness