FDA.reportPublic FDA data

FDA label 4a4c2344-5cf8-989a-e063-6294a90a7b81

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
37e918b0-5084-c0a0-e063-6394a90aeb3e
SPL ID
4a4c2344-5cf8-989a-e063-6294a90a7b81
Version
2
Effective date
2026-02-08
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:10

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine,This medicine is believed to be safer than smoking.However, the risks to your child from this medicine are not fully known

warnings

Do not use Do not wear more than one patch at a time.Do not cut patch in half or into smaller pieces,Do not leave patch on for more than 24 hours.because it may irritate your skin and loses strength after 24 hours.To avoid possible burns, remove patch before undergoing any MRl (magnetic resonance imaging)procedures.It is important to complete treatment,if you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.