Label: NICOTINE TRANSDERMAL SYSTEM- nicotine patch, extended release
- NDC Code(s): 49035-194-01, 49035-194-02, 49035-195-02, 49035-196-02
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated December 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Step 1 (in each patch)
- Active ingredient Step 2 (in each patch)
- Active ingredient Step 3 (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
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- heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
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- high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
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- an allergy to adhesive tape or have skin problems because you are more likely to get rashes
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- stomach ulcers or diabetes
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- history of seizures
Ask a doctor or pharmacist before use if you are
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- using a non-nicotine stop smoking drug
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- taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
When using this product
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- if you have vivid dreams or other sleep disturbances remove this patch at bedtime
Stop use and ask a doctor if
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- skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
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- irregular heartbeat or palpitations occur
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- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat
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- you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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Directions
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- if you are under 18 years of age, ask a doctor before use
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- before using this product, read the enclosed User’s Guide for complete directions and other information
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- begin using the patch on your quit day
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- if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule:
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 1-6
Weeks 7-8
Weeks 9-10
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- if you smoke 10 or less cigarettes per day, do not use STEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks, then STEP 3 (7 mg) for 2 weeks and then stop.
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- steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
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- apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.
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- remove backing from patch and immediately press onto skin. Hold for 10 seconds.
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- wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.
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- you may wear the patch for 16 or 24 hours.
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- if you crave cigarettes when you wake up, wear the patch for 24 hours.
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- if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
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- the used patch should be removed and a new one applied to a different skin site at the same time each day
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- do not wear more than one patch at a time
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- do not cut patch in half or into smaller pieces
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- do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
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- 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 healthcare provider.
- Other information
- Inactive ingredients
- Questions or comments?
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Generic Section
Read carton and enclosed User’s Guide before using this product. Keep this carton and User’s Guide. They contain important information.
Includes User’s Guide with behavioral support program enrollment offer.
To increase your success in quitting:
- 1.
- You must be motivated to quit.
- 2.
- Complete the full treatment program, applying a new patch every day.
- 3.
- Use with a support program as described in the enclosed User’s Guide.
For your family’s protection, nicotine patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn.
What is the nicotine patch and how is it used?
The nicotine patch is a small, nicotine-containing patch. When you put on a nicotine patch, nicotine passes through the skin and into your body. The nicotine patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16 or 24 hour period you wear the nicotine patch. This helps to reduce cravings you may have for nicotine.
READ THE LABEL
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- Not for sale to those under 18 years of age.
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- Proof of age required.
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- Not for sale in vending machines or from any source where proof of age cannot be verified.
Satisfaction guaranteed – Or we’ll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
DISTRIBUTED BY: Walmart Inc.
Bentonville, AR 72716
PRODUCT OF IRELAND
*NICODERM and CQ are trademarks owned by or licensed to the GSK group of companies.
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PRINCIPAL DISPLAY PANEL (21 mg, 14 patches)
NDC 49035-194-02
equate
Compare to NicoDerm® CQ® active ingredient*
CLEAR
Nicotine Transdermal System
21 mg Delivered Over 24 Hours
Stop Smoking Aid
STEP 1
21 mg
14 PATCHES
(2-week Kit)
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
The full course of treatment for STEP 1 is 42 patches (6 weeks); this package contains 14 patches (2-week course) only. Read the enclosed User’s Guide for additional information.
14 CLEAR PATCHES (2-WEEK KIT)
-
PRINCIPAL DISPLAY PANEL
NDC 49035-195-02
equate
Compare to NicoDerm® CQ® active ingredient*
CLEAR
Nicotine Transdermal System
14 mg Delivered Over 24 Hours
Stop Smoking Aid
STEP 2
14 mg
14 PATCHES
(2-week Kit)
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
The full course of treatment for STEP 2 is 2 or 6 weeks (depending on how many cigarettes you smoke per day). Read the enclosed User’s Guide for additional information.
14 CLEAR PATCHES (2-WEEK KIT)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NICOTINE TRANSDERMAL SYSTEM
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-194 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 HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-194-02 14 in 1 CARTON 10/19/2010 1 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:49035-194-01 7 in 1 CARTON 10/19/2010 2 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA020165 10/19/2010 NICOTINE TRANSDERMAL SYSTEM
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-195 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 HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-195-02 14 in 1 CARTON 10/19/2010 1 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA020165 10/19/2010 NICOTINE TRANSDERMAL SYSTEM
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-196 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 HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-196-02 14 in 1 CARTON 10/19/2010 1 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA020165 10/19/2010 Labeler - Wal-Mart Stores Inc (051957769)
