Label: NICORETTE FRUIT CHILL- nicotine polacrilex gum, chewing

  • NDC Code(s): 0135-0241-02, 0135-0241-03, 0135-0241-05, 0135-0241-06, view more
    0135-0241-08, 0135-0241-11, 0135-0241-14, 0135-0241-15, 0135-0241-17, 0135-0241-18, 0135-0241-19, 0135-0242-02, 0135-0242-03, 0135-0242-05, 0135-0242-06, 0135-0242-08, 0135-0242-11, 0135-0242-14, 0135-0242-15, 0135-0242-17, 0135-0242-18, 0135-0242-19
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 20, 2024

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

  • Active ingredient (in each chewing piece)

    Nicotine polacrilex (equal to 2 mg nicotine)

    Nicotine polacrilex (equal to 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 a 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
    • 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 2mg nicotine gum
    • if you smoke your first cigarette within 30 minutes of waking up,use 4mg 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 94 mg, sodium 11 mg
    • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
    • store at 20 -25 oC (68 - 77 oF)
    • protect from light
  • Inactive ingredients

    each 4 mg piece contains:acacia, acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

  • Questions or comments?

    call toll-free 1-800-419-4766 

    TO INCREASE YOUR SUCCESS IN QUITTING:

    • You must be motivated to quit.
    • Use Enough– Chew at least 9 piecesof Nicorette ®gum per day during the first six weeks.
    • Use Long Enough– Use Nicorette ®gum for the full 12 weeks.
    • Use with a support programas directed in the enclosed User’s Guide.

    To remove the gum, tear off single unit.

    Peel off backing, starting at corner with loose edge.

    Push gum through foil.

    • 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

    This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.

    Distributed by

    GlaxoSmithKlineConsumer Healthcare

    Warren, NJ 07059

    Made in Sweden

    © 2016 GSK or its licensor. All rights reserved.

    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.Nicorette.comor see inside for more details.

  • Principal Display Panel

    NDC 0135-0241-05

    Nicorette ®

    nicotine polacrilex gum, 2mg • stop smoking aid

    Gum

    Coated

    FOR BOLD FLAVOR

    Fruit Chill®

    2 mg

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

    If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

    160 PIECES,2mg EACH

    30856XG

    30856XG_Nicorette Fruit Chill 2 mg_160 ct.JPG
  • Principal Display Panel

    NDC 0135-0242-05

    Nicorette ®

    nicotine polacrilex gum, 4mg • stop smoking aid

    Gum

    Coated

    FOR BOLD FLAVOR

    Fruit Chill ®

    4 mg

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

    If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

    160 PIECES,4 mg EACH

    30857XG

    30857XG_Nicorette Fruit Chill 4 mg_160 ct.JPG
  • INGREDIENTS AND APPEARANCE
    NICORETTE   FRUIT CHILL
    nicotine polacrilex gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0241
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLACRILIN (UNII: RCZ785HI7S)  
    ACACIA (UNII: 5C5403N26O)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeSQUARESize15mm
    FlavorFRUIT (fruit chill) Imprint Code N2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0241-021 in 1 CARTON09/14/2009
    1100 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0135-0241-031 in 1 CARTON09/14/200908/01/2019
    2190 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0135-0241-051 in 1 CARTON09/14/2009
    3160 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0135-0241-061 in 1 CARTON09/14/2009
    420 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0135-0241-0820 in 1 CARTON; Type 0: Not a Combination Product09/14/2009
    6NDC:0135-0241-111 in 1 CARTON09/14/200908/01/2018
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:0135-0241-1425 in 1 CARTON; Type 0: Not a Combination Product09/14/200908/01/2018
    8NDC:0135-0241-158 in 1 PACKAGE09/14/200908/01/2018
    825 in 1 CARTON; Type 0: Not a Combination Product
    9NDC:0135-0241-172 in 1 PACKAGE08/01/2014
    910 in 1 CARTON
    910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10NDC:0135-0241-1812 in 1 CARTON09/01/2018
    1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:0135-0241-1918 in 1 CARTON12/03/2018
    1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01861209/14/2009
    NICORETTE   FRUIT CHILL
    nicotine polacrilex gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLACRILIN (UNII: RCZ785HI7S)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeSQUARESize15mm
    FlavorFRUIT (fruit chill) Imprint Code N4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0242-021 in 1 CARTON09/14/2009
    1100 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0135-0242-031 in 1 CARTON09/14/200908/01/2019
    2190 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0135-0242-051 in 1 CARTON09/14/2009
    3160 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0135-0242-061 in 1 CARTON09/14/2009
    420 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0135-0242-0820 in 1 CARTON; Type 0: Not a Combination Product09/14/2009
    6NDC:0135-0242-111 in 1 CARTON09/14/2009
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:0135-0242-1425 in 1 CARTON; Type 0: Not a Combination Product09/14/200908/01/2018
    8NDC:0135-0242-158 in 1 PACKAGE09/14/200908/01/2018
    825 in 1 CARTON; Type 0: Not a Combination Product
    9NDC:0135-0242-172 in 1 PACKAGE08/01/2014
    910 in 1 CARTON
    910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10NDC:0135-0242-1812 in 1 CARTON09/01/2018
    1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:0135-0242-1918 in 1 CARTON12/03/2018
    1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02006609/14/2009
    Labeler - Haleon US Holdings LLC (079944263)