Label: NICORETTE WHITE MINT NICOTINE POLACRILEX- nicotine gum, chewing

  • NDC Code(s): 29485-5271-1
  • Packager: Mechanical Servants LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 29, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewing piece)

    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 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

    • 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 6Weeks 7 to 9Weeks 10 to 12
    1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 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

    • each piece contains: calcium 94 mg, sodium 13 mg
    • store at 20 - 25°C (68 - 77°F)
    • protect from light
  • Inactive ingredients

    acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

  • Questions or comments?

    call toll-free 1-800-419-4766

  • SPL UNCLASSIFIED SECTION

    Repackaged and Distributed with Permission of the Manufacturer by
    Convenience Valet®, Melrose Park, IL 60160

  • PRINCIPAL DISPLAY PANEL - 10 Piece Blister Pack Carton

    This package size may not be
    a full day's supply; it is intended
    to start or continue a quit attempt.

    NDC 0135-0475-17

    gsk

    Nicorette®
    nicotine polacrilex gum, 4 mg • stop smoking aid
    Gum

    4
    mg

    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 Nicorette® 2 mg Gum

    Coated
    FOR BOLD FLAVOR

    White Ice Mint®

    10 PIECES, 4 mg EACH

    PRINCIPAL DISPLAY PANEL - 10 Piece Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    NICORETTE WHITE MINT NICOTINE POLACRILEX 
    nicotine gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-5271
    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)  
    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
    FlavorMINTImprint Code N4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-5271-11 in 1 CARTON06/29/2009
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02006606/29/2009
    Labeler - Mechanical Servants LLC (005530951)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mechanical Servants LLC005530951REPACK(29485-5271) , RELABEL(29485-5271)
    Establishment
    NameAddressID/FEIBusiness Operations
    GlaxoSmithKline046877908MANUFACTURE(29485-5271)