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U.S. Department of Health and Human Services

Safety

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Nicorette (nicotine polacrilex) 2 mg and 4 mg gum (OTC)

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

 

August 2014

Summary View

IMPORTANT WARNINGS

Stop and ask a doctor if

  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)…

 

September 2011

Summary View

DRUG FACTS

Some Important Warnings
  • Stop use and ask a doctor if...oral blistering occurs