Nicotine Transdermal System step 3

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)

Brand name
Nicotine Transdermal System step 3
Generic name
NICOTINE
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Product type
HUMAN OTC DRUG
SPL set ID
dbbed17b-8ad3-05fb-fb63-03fbb75eae05
SPL ID
2ffcf657-7e4f-d67f-1bf7-38bd7fb4946a
Version
1
Effective date
2026-03-18
Source export date
2026-08-17
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/2026-08-17/559e90e291f706011ac4a15e81427bf26ca36e5d0b9d84e84d297d7c5834404b/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 06:59:44
Harmonized routes table
Harmonized routes
TRANSDERMAL

Warnings cross-check#

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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 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. Ask a doctor before use if you have heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. 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 a non-nicotine stop smoking drug • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product • if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur. you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat. you have symptoms of an allergic reaction (such as difficulty breathing or rash). Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222). Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.