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Label Changes for:

Gelnique (oxybutynin chloride), 3 percent gel

January 2013

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

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


January 2013


5.5 Central Nervous System Effects
  • Drugs containing oxybutynin are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.1)]. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly .....