Label: NICODERM CQ- nicotine patch, extended release

  • NDC Code(s): 0135-0145-02, 0135-0194-01, 0135-0194-02, 0135-0194-03, view more
    0135-0194-05, 0135-0194-08, 0135-0195-02, 0135-0195-03, 0135-0195-05, 0135-0195-08, 0135-0196-02, 0135-0196-05, 0135-0196-08
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 29, 2022

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

  • Active ingredient (in each patch)(clear)

    Nicotine, 21 mg delivered over 24 hours

  • Active ingredient (in each patch)(clear)

    Nicotine, 14 mg delivered over 24 hours

  • Active ingredient (in each patch)(clear)

    Nicotine, 7 mg delivered over 24 hours

  • Active ingredient (in each patch)(opaque)

    Nicotine, 21 mg delivered over 24 hours

  • Purpose

    Stop smoking aid

  • Uses

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

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

  • Directions (Clear)

    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
    begin using the patch on your quit day
    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

    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.
    steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
    apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.
    remove backing from patch and immediately press onto skin. Hold for 10 seconds.
    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.
    you may wear the patch for 16 or 24 hours
    if you crave cigarettes when you wake up, wear the patch for 24 hours
    if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
    the used patch should be removed and a new one applied to a different skin site at the same time each day
    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.
  • Directions (Opaque)

    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 follow 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

    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.
    steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
    apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.
    remove backing from patch and immediately press onto skin. Hold for 10 seconds.
    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.
    you may wear the patch for 16 or 24 hours
    if you crave cigarettes when you wake up, wear the patch for 24 hours
    if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
    to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
    the used patch should be removed and a new one applied to a different skin site at the same time each day
    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

    store at 20-25°C (68-77°F)
  • Inactive ingredients (Clear)

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

  • Inactive ingredients (Opaque)

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

  • Questions or comments?

    call toll-free 1-800-834-5895

  • Principal Display Panel

    NDC 0135-0194-02

    NicoDerm

    CQ

    Nicotine Transdermal System 21 mg Delivered over 24 Hours

    STOP SMOKING AID

    CLEAR PATCH

    EXTENDED RELEASE 24 HOURS

    SMARTCONTROL TECHNOLOGY

    STEP 1

    21MG

    IF YOU SMOKE MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1

    10 OR LESS CIGARETTES A DAY, START WITH STEP 2

    ACTUAL SIZE

    14 clear patches (2-week kit)

    What is the NicoDerm CQ Patch and How is it Used?

    NicoDermCQ is a small, nicotine-containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDermCQ 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 NicoDermCQ patch. This helps to reduce cravings you may have for nicotine.

    READ THE LABEL

    Not for sale to those 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.

    Trademarks are owned by or licensed to the GSK group of companies.

    For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.com or see inside for more details.

    U.S. Patent No. 7,622,136

    8,075,911

    Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information.

    Includes Committed Quitters Program enrollment offer and User's Guide.

    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, NicoDermCQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

    Manufactured by ALZA Corporation,

    Vacaville, CA 95688 for

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2017 GSK or its licensor.

    106192XA

    106192XA_Nicoderm CQ 21 mg_14 patches.JPG
  • Principal Display Panel

    NDC 0135-0195-02

    NicoDerm

    CQ

    Nicotine Transdermal System 14 mg Delivered over 24 Hours

    STOP SMOKING AID

    CLEAR PATCH

    EXTENDED RELEASE 24 HOURS

    SMARTCONTROL TECHNOLOGY

    STEP 2

    IF YOU SMOKE 10 OR LESS CIGARETTES A DAY, START WITH STEP 2

    MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1

    ACTUAL SIZE

    14 clear patches (2-week kit)

    What is the NicoDerm CQPatch and How is it Used?

    NicoDermCQ is a small, nicotine-containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDermCQ 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 NicoDermCQ patch. This helps to reduce cravings you may have for nicotine.

    READ THE LABEL

    Not for sale to those 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.

    Trademarks are owned by or licensed to the GSK group of companies.

    For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.com or see inside for more details.

    U.S. Patent No. 7,622,136

    8,075,911

    Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information

    Includes Committed Quitters Program enrollment offer and User's Guide.

    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, NicoDermCQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

    Manufactured by ALZA Corporation,

    Vacaville, CA 95688 for

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2017 GSK or its licensor.

    106195XA

    106195XA_Nicoderm CQ 14 mg_14 patches.JPG
  • Principal Display Panel

    NDC 0135-0196-02

    NicoDerm

    CQ

    Nicotine Transdermal System 7 mg Delivered over 24 Hours

    STOP SMOKING AID

    CLEAR PATCH

    EXTENDED RELEASE 24 HOURS

    SMARTCONTROL TECHNOLOGY

    STEP 3

    FOR USE AFTER COMPLETING STEP 2

    ACTUAL SIZE

    14 clear patches (2-week kit)

    What is the NicoDerm CQ Patch and How is it Used?

    NicoDermCQ is a small, nicotine-containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDermCQis 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 NicoDermCQ patch. This helps to reduce cravings you may have for nicotine.

    READ THE LABEL

    Not for sale to those 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.

    Trademarks are owned by or licensed to the GSK group of companies.

    For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.com or see inside for more details.

    U.S. Patent No. 7,622,136

    8,075,911

    Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information

    Includes Committed Quitters Program enrollment offer and User's Guide.

    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, NicoDermCQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

    Manufactured by ALZA Corporation,

    Vacaville, CA 95688 for

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2017 GSK or its licensor.

    106194XA

    106194XA_Nicoderm CQ 7 mg_14 patches.JPG
  • Principal Display Panel

    NDC 0135-0145-02

    NicoDerm

    CQ

    Nicotine Transdermal System 21 mg Delivered over 24 Hours

    STOP SMOKING AID

    OPAQUE PATCH

    EXTENDED RELEASE 24 HOURS

    SMARTCONTROL TECHNOLOGY

    NEW DIRECTIONS FOR USE

    - Keep Using if You Slip Up and Have a Cigarette

    - Use Beyond 10 Weeks if Needed to Quit

    STEP 1

    IF YOU SMOKE MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1

    10 OR LESS CIGARETTES A DAY, START WITH STEP 2

    ACTUAL SIZE

    14 clear patches (2-week kit)

    What is the NicoDermCQ Patch and How is it Used?

    NicoDermCQ is a small, nicotine-containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDermCQ 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 NicoDermCQpatch. This helps to reduce cravings you may have for nicotine.

    READ THE LABEL

    Not for sale to those 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.

    NICODERM, NICODERM BURST DESIGN, CQ, COMMITTED QUITTERS, MAN ON STEP Device, SMARTCONTROL are trademarks owned by or licensed to the GSK group of companies.

    For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.com or see inside for more details.

    U.S. Patent No. 7,622,136

    8,075,911

    Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information

    Includes Committed Quitters Program enrollment offer and User's Guide.

    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, NicoDermCQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

    Manufactured by ALZA Corporation,

    Vacaville, CA 95688 for

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2014 GSK

    102838XB

    102838XB_Nicoderm CQ 21 mg Opaque_14patches.jpg
  • INGREDIENTS AND APPEARANCE
    NICODERM  CQ
    nicotine patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0194
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0194-017 in 1 CARTON05/12/2011
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0135-0194-0214 in 1 CARTON05/12/2011
    224 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0135-0194-031 in 1 PACKAGE05/12/2011
    321 in 1 CARTON
    324 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:0135-0194-0514 in 1 CARTON05/12/2011
    4NDC:0135-0194-0824 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02016505/12/2011
    NICODERM  CQ
    nicotine patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0195
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0195-0214 in 1 CARTON05/12/2011
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0135-0195-031 in 1 PACKAGE05/12/2011
    221 in 1 CARTON
    224 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0135-0195-0514 in 1 CARTON05/12/2011
    3NDC:0135-0195-0824 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02016505/12/2011
    NICODERM  CQ
    nicotine patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0196
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE7 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0196-0214 in 1 CARTON05/12/2011
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0135-0196-0514 in 1 CARTON05/12/2011
    2NDC:0135-0196-0824 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02016505/12/2011
    NICODERM  CQ
    nicotine patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0145
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Product Characteristics
    ColorWHITE (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0145-0214 in 1 CARTON05/12/201109/01/2018
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02016505/12/201109/01/2018
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)