FDA label f1e21048-6b54-df20-e053-2a95a90ae667

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
c2cedf57-f7b4-6a71-e053-2995a90a949e
SPL ID
f1e21048-6b54-df20-e053-2a95a90ae667
Version
2
Effective date
2023-01-09
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:09:36

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare provider.Smoking can seriously harm your child.Try to stop smoking without using any nicotine replacement medicine.This medicine is believed to safer than smoking.However, the risks to your child from this medicine are not full known. Ask a doctor before use if you have *heart disease, recent heartattack, or irregular heartbeat.Nicotine can increase your heartrate. *high blood pressure not controlled with medication.Nicotine can increase your blood pressure. *an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. *stomach ulcer or diabetes. *history of seizures. Ask a doctor or pharmacist before use if you are *using an on-nicotine stop smoking drug *taking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted

Reported adverse events (FAERS/openFDA)#

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