Skip to Content

Label Changes for:

Habitrol Patch (nicotine transdermal system)

July 2016

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

July 2016

Consumer Information Leaflet

How to Use the Patch (additions)

  • Ask a doctor before use if you have stomach ulcer or diabetes.
  • Ask a doctor before use if you have history of seizures.
  • Stop use and ask a doctor if you have symptoms of an allergic reaction (such as difficulty breathing or rash)

 

May 2016

WARNINGS and PATIENT PACKAGE INSERT

Ask a doctor before use if you have (add the following two bullets to this section)

  • stomach ulcer or diabetes.
  • history of seizures.

Stop use and ask a doctor if… (add)

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

 

Hide