Label: NICOTINE TRANSDERMAL SYSTEM- nicotine film, extended release
- NDC Code(s): 76282-781-40, 76282-782-40, 76282-783-40
- Packager: EXELAN PHARMACEUTICALS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 1, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each patch)
- Active ingredient (in each patch)
- Active ingredient (in each patch)
- Purpose
- Use
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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 the 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)
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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:
Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 Step 1 Step 2 Step 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day - 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
- 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.
- Other information
- Inactive ingredients
- Questions or comments?
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TO INCREASE YOUR SUCCESS IN QUITTING:
- You must be motivated to quit.
- Use one patch daily according to directions.
- It is important to complete treatment
- If you feel you need to use patch for a longer period to keep from smoking, talk to your health care provider.
- Use patch with a behavioral support program, such as the one described in the enclosed booklet.
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON
Exelan
NDC 76282-783-40
Clear
Nicotine Transdermal
System Patch
21 mg
21 mg delivered over 24 hours
STOP SMOKING AID
Includes Behavior Support Program with Self-Help Guide
If you smoke MORE than 10 cigarettes per day: Start with Step 1.
If you smoke 10 or LESS cigarettes per day: Start with Step 2.
STEP ONE
14 PATCHES
-
PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON
Exelan
NDC 76282-782-40
Clear
Nicotine Transdermal
System Patch
14 mg
14 mg delivered over 24 hours
STOP SMOKING AID
Includes Behavior Support Program with Self-Help Guide
If you smoke MORE than 10 cigarettes per day: Start with Step 1.
If you smoke 10 or LESS cigarettes per day: Start with Step 2.
STEP ONE
14 PATCHES
-
PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON
Exelan
NDC 76282-781-40
Clear
Nicotine Transdermal
System Patch
7 mg
7 mg delivered over 24 hours
STOP SMOKING AID
Includes Behavior Support Program with Self-Help Guide
If you smoke MORE than 10 cigarettes per day: Start with Step 1.
If you smoke 10 or LESS cigarettes per day: Start with Step 2.
STEP ONE
14 PATCHES
-
INGREDIENTS AND APPEARANCE
NICOTINE TRANSDERMAL SYSTEM
nicotine film, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76282-783 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 21 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76282-783-40 14 in 1 CARTON 10/13/2025 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/13/2025 NICOTINE TRANSDERMAL SYSTEM
nicotine film, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76282-782 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 14 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76282-782-40 14 in 1 CARTON 10/13/2025 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/13/2025 NICOTINE TRANSDERMAL SYSTEM
nicotine film, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76282-781 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 7 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76282-781-40 14 in 1 CARTON 10/13/2025 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/13/2025 Labeler - EXELAN PHARMACEUTICALS, INC. (967795266) Registrant - EXELAN PHARMACEUTICALS, INC. (967795266) Establishment Name Address ID/FEI Business Operations Aveva Drug Delivery Systems Inc. 783982093 analysis(76282-783, 76282-782, 76282-781) , label(76282-783, 76282-782, 76282-781) , manufacture(76282-783, 76282-782, 76282-781) , pack(76282-783, 76282-782, 76282-781) Establishment Name Address ID/FEI Business Operations Aveva Drug Delivery Systems Inc. 118415519 manufacture(76282-781, 76282-782, 76282-783) , label(76282-781, 76282-782, 76282-783) , pack(76282-781, 76282-782, 76282-783)