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Nicotine transdermal system step 2
nicotine · Nicotine transdermal system step 2 is a cholinergic nicotinic agonist (over-the-counter) containing nicotine, made by Chain Drug Marketing Association INC.
- Type
- Over the counter
- Drug class
- Cholinergic Nicotinic Agonist
- Route
- Transdermal
- Manufacturers
- 1
- + 1 repackager labels
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Drug facts
- Generic name
- nicotine
- Active ingredients
- Nicotine
- Drug class
- Cholinergic Nicotinic Agonist
- Dosage forms
- Patch, extended release
- Label holder
- Chain Drug Marketing Association INC
- FDA application
- NDA020076
- Label updated
- 07/25/2024
Active ingredients
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
Purpose
Stop smoking aid
Uses
Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Directions
- If you are under 18 years of age, ask a doctor before use
- Before using this product, read the enclosed self-help guide for complete directions and other information
- Begin using the patch on your quit day
- If you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-4 Weeks 5-6 Weeks 7-8
- If you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks
- Apply one new patch every 24 hours on skin that is dry, clean and hairless
- Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
- Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
- The used patch should be removed and a new one applied to a different skin site at the same time each day
- If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
- 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 MRI (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.
Warnings
SECTION 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.
- Save pouch to use for patch disposal.
- Dispose of the used patches by folding sticky ends together and putting in pouch.
Ask a doctor before use
- 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
- 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
- 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.
- Save pouch to use for patch disposal.
- Dispose of the used patches by folding sticky ends together and putting in pouch.
Inactive ingredients
Acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer
Questions?
Call 1-800-585-8682 Weekdays (9am-8pm ET) or visit us at www.habitrol.com TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use one patch daily according to directions. 3. It is important to complete treatment. 4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider. 5. Use patch with a behavioural support program, such as the one described in the enclosed booklet. For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn.
- Not for sale to persons under 18 years of age.
- Proof of age required.
- Not for sale in vending machines or from any source where proof of age cannot be verified.
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Patch, extended release | 14 mg/24h | transdermal | 1 |
| Patch, extended release | 21 mg/24h | transdermal | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 40,213 reports that list nicotine, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug ineffective5,266
- Nausea3,270
- Application site erythema3,142
- Application site pruritus3,069
- Nicotine dependence2,751
- Dizziness1,910
- Headache1,645
- Malaise1,636
- Wrong technique in product usage process1,257
- Vomiting1,255
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label · 1 from repackagers
Repackager labels (1)
- Chain Drug Marketing Association INC07/25/2024
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIIDrugOngoing06/03/2026Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES...AVEVA Drug Delivery Systems, Inc. · Failed Impurities/Degradation Specifications: Elevated levels of...
- Class IIIDrug10/07/2020Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By...P & L Developments, LLC · Labeling: Incorrect or Missing Package Insert: The package insert...
- Class IIIDrug09/03/2014Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave...Perrigo Holland Inc · Failed Dissolution Specifications and Failed Tablet...
- Class IIIDrug04/30/2014Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials....GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · 10 products · Failed Lozenge Specifications; Lozenges are overly thick, overly...
- Class IIDrug01/29/2014NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.Aidapak Services, LLC · 2 products · Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have...
Nicotine transdermal system step 2: common questions
- What is Nicotine transdermal system step 2 used for?
- reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Is Nicotine transdermal system step 2 a prescription drug?
- No. Nicotine transdermal system step 2 is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Nicotine transdermal system step 2?
- Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
- Who makes Nicotine transdermal system step 2?
- Chain Drug Marketing Association INC lists Nicotine transdermal system step 2 with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/25/2024 · Label text is shown as published by the manufacturer. Not medical advice