Nicotine is an over-the-counter medicine (Cholinergic Nicotinic Agonist). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Drug class
- Cholinergic Nicotinic Agonist
- Taken
- Transdermal
- Label
- AmerisourceBergen Drug Corporation, revised July 1, 2026 · full label on DailyMed
Purpose
Stop smoking aid
What it is used for
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Active ingredient
Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours
Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours
Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours
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).
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.
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.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Nicotine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class III Ongoing
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Lots, distribution and details
- Lots / codes
- Lot #: 56841, Expires: 03/2028
- Distribution
- Nationwide within the U.S
- Quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Recall started
- May 14, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0550-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Nicotine
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID e51d2c09-a20f-eb9b-e3e4-013f3e488ab3.