Label: NICOTINE POLACRILEX COATED CINNAMON- nicotine polacrilex gum, chewing

  • NDC Code(s): 69842-026-44, 69842-028-44
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 22, 2019

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

  • Drug Facts

  • Active ingredient (in each chewing piece) - 2 mg

    Nicotine Polacrilex 2 mg (nicotine)

  • Active ingredient (in each chewing piece) - 4 mg

    Nicotine Polacrilex 4 mg (nicotine)

  • Purpose

    Stop smoking aid

  • Use

    • 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

    • a sodium-restricted diet
    • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
    • high blood pressure not controlled with medication. Nicotine can increase blood pressure.
    • 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 prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. 
  • Stop use and ask a doctor if

    • mouth, teeth, or jaw problems occur
    • irregular heartbeat or palpitations occur
    • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat
    • oral blistering occurs
    • you have symptoms of an allergic reaction (such as difficulty breathing or rash)
  • Keep out of reach of children and pets.

    Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions - 2 mg

    • 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 important information
    • begin using the gum on your quit day
    • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum
    • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule:
      Weeks 1 to 6    Weeks 7 to 9    Weeks 10 to 12 

    1 piece every
    1 to 2 hours

    1 piece every
    2 to 4 hours 
    1 piece every
    4 to 8 hours
    • nicotine gum is a medicine and must be used a certain way to get the best results
    • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
    • repeat this process until most of the tingle is gone (about 30 minutes)
    • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
    • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
    • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
    • do not use more than 24 pieces a day
    • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider. 
  • Directions - 4 mg

    • 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 important information
    • begin using the gum on your quit day
    • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum
    • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:
      Weeks 1 to 6    Weeks 7 to 9    Weeks 10 to 12 

    1 piece every
    1 to 2 hours

    1 piece every
    2 to 4 hours 
    1 piece every
    4 to 8 hours
    • nicotine gum is a medicine and must be used a certain way to get the best results
    • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
    • repeat this process until most of the tingle is gone (about 30 minutes)
    • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
    • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
    • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
    • do not use more than 24 pieces a day
    • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider. 
  • Other information - 2 mg

    • each piece contains: calcium 115 mg, sodium 11 mg
    • store at 20 - 25ºC (68 - 77ºF)
    • protect from light
  • Other information - 4 mg

    • each piece contains: calcium 115 mg, sodium 11 mg
    • store at 20 - 25ºC (68 - 77ºF)
    • protect from light
  • Inactive ingredients - 2 mg

    acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

  • Inactive ingredients - 4 mg

    acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

  • Questions or comments?

    Call 1-877-440-7867

  • TO INCREASE YOUR SUCCESS IN QUITTING:

    1. You must be motivated to quit.
    2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.
    3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.
    4. Use with a support program as directed in the enclosed User's Guide.
    Instructions

    Blister packaged for your protection.
    Do not use if individual seals are open or torn.

    • 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.

     

  • PRINCIPAL DISPLAY PANEL - 2 mg

    CVSHealth   

    Compare to the active ingredient in Nicorette® Cinnamon Surge™ Coated Gum*

    Sugar Free
    Nicotine Gum

    2 mg

    Nicotine Polacrilex Gum USP,
    2 mg (nicotine)

    Free Audio CD
    upon request.
    See inside.

    STOP SMOKING AID

    FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE
    MORE THAN 30 MINUTES AFTER WAKING UP.

    If you smoke your first cigarette WITHIN 30 MINUTES
    of waking up, use Nicotine Polacrilex Gum USP, 4 mg

    Coated Cinnamon

    100 PIECES, 2 mg EACH


    2 mg coated cinnamon 100 count

     

  • PRINCIPAL DISPLAY PANEL - 4 mg

    CVSHealth
      
    Compare to the active ingredient in Nicorette® Cinnamon Surge™ Coated Gum*

    Sugar Free
    Nicotine Gum

    4 mg

    Nicotine Polacrilex Gum USP,
    4 mg (nicotine)

    Free Audio CD
    upon request.
    See inside.

    STOP SMOKING AID

    FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE
    WITHIN 30 MINUTES OF WAKING UP.

    If you smoke your first cigarette MORE THAN 30 MINUTES
    after waking up, use Nicotine Polacrilex Gum USP, 2 mg

    Coated Cinnamon

    100 PIECES, 4 mg EACH

    4 mg coated cinnamon 100 count

  • INGREDIENTS AND APPEARANCE
    NICOTINE POLACRILEX  COATED CINNAMON
    nicotine polacrilex gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-026
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeSQUARESize14mm
    FlavorCINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-026-44100 in 1 CARTON01/01/2014
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07921601/01/2014
    NICOTINE POLACRILEX  COATED CINNAMON
    nicotine polacrilex gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-028
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeSQUARESize14mm
    FlavorCINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-028-44100 in 1 CARTON01/01/2014
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07921901/01/2014
    Labeler - CVS Pharmacy (062312574)