Label: NICOTINE TRANSDERMAL SYSTEM- nicotine patch, extended release 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each patch)

    Nicotine, 21 mg delivered over 24 hours

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  • Purpose

    Stop smoking aid

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  • Use

    reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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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.

    Do Not Use

    if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products

    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.

    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

    do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch.
    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

    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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

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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 User’s Guide for complete directions and other information
    stop smoking completely when you begin using the patch
    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 7mg patch/day
     
    Weeks 1-6
     
    Weeks 7-8
     
    Weeks 9-10
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  • Other information

    store at 20-25°C (68-77°F)

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  • Inactive ingredients

    ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

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  • Questions or comments?

    call toll-free 1-866-255-5205 (English/Spanish) weekdays

    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/packet is damaged or open.
     
    Nicotine transdermal system 21 mg delivered over 24 hours
     
    Stop smoking aid
    Not for sale to those under 18 years of age.
    Prrof of age required.
    Not for sale in vending machines or from any source where proof of age cannot be verified
     
    Free Audio CD upon request. See inside.
     
    What is the Nicotine Patch and How is it Used?
     
    Nicotine Patch is a small, nicotine-containing patch. When you put on a Nicotine Patch nicotine passes through the skin and into your body. 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 24 or 16-hour period you wear the Nicotine Patch. This helps to reduce cravings you may have for nicotine.
     
    Read carton and enclosed User’s Guide before using this product. Keep the carton and User’s Guide. They contain important information.
     
    THE SIMPLY RIGHT™ PROMISE
     
    Simply Right is dedicated to providing healthful, gentle, and safe personal care products for the entire family. We continuously strive to be your trusted partner in wellness and exceed your expectations.
     
    We would like to hear from you with any comments or suggestions. In the continental US or Canada, you can call us toll-free at 1-800-255-5205, Monday through Friday, from 8 am to 5 pm CST. Or you can send us an email at samsclub.com.
     
    Distributed by:
     
    SAM’S West, Inc.
     
    Bentonville, AR 72716
     
    *NICODERM is a licensed trademark of the GlaxoSmithKline group of companies.
     
    SATISFACTION GUARENTEED BY REFUND OR EXCHANGE
     
    Made in Switzerland
     
    Send comments/questions to:
     
    GCSP 5.4376.4C
     
    Consumer Relations
     
    P.O. Box 13398
     
    Research Triangle Park, NC 27709-9627
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  • Principal Display Panel

    NDC 68196-194-03

    nicotine patch

    Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid

    Compare to NicoDerm®CQ®*

    SIMPLY RIGHT

    Health Care

    Includes behavior support program enrollment form & user’s 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

    21 mg

    step 1

    21 clear patches

    ©2011

    101775XA

    101775XA Nicotine Patch Sams 21 mg 21 ct carton
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  • INGREDIENTS AND APPEARANCE
    NICOTINE  TRANSDERMAL SYSTEM
    nicotine patch, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68196-194
    Route of Administration TRANSDERMAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 21 mg  in 24 h
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)  
    HIGH DENSITY POLYETHYLENE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-194-03 21 in 1 CARTON
    1 24 h in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020165 03/02/2012
    Labeler - Sam's West Inc (051957769)
    Registrant - sanofi-aventis U.S. LLC (011330557)
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