Label: NICORETTE 4MG CINNAMON SURGE- nicotine polacrilex gum, chewing

  • NDC Code(s): 66715-8123-0
  • Packager: Lil' Drug Store products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 8, 2024

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

  • Drug Facts

    ​Drug Facts

  • Active ingredient

    Active ingredient (in each chewing piece)

    Nicotine polacrilex (equal to 4 mg nicotine)

    Purpose

    ​Purpose

    Stop smoking aid

  • Use

    Use

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

    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

    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

    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.

    Stop use and ask a doctor

    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

    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

    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

    Other information

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

    Inactive ingredients

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

  • Questions or comments?

    Questions or comments? call toll-free 1-800-419-4766

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Haleon, Warren, NJ 07059
    Made in Sweden ©2023 Haleon group of companies or its licensor.
    Trademarks are owned by or licensed to the Haleon group of companies.

    Packaged and distributed with permission of Haleon by:
    Lil’ Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404
    1-877-507-6516 (8AM - 4:30 PM CST)

  • Nicorette 4mg Cinnamon Surge, Lil' Drug Store ® - PDP/Package

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

    Nicorette

    nicotine polacrilex gum, 4 mg • stop smoking aid

    Gum

    [product image]

    Coated

    FOR BOLD FLAVOR

    Cinnamon Surge

    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.

    10 PIECES, 4 mg EACH

    [Lil' Drug Store ® logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    NICORETTE 4MG CINNAMON SURGE 
    nicotine polacrilex gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-8123
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    ACACIA (UNII: 5C5403N26O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Colorwhite ((cream)) Scoreno score
    ShapeSQUARESize15mm
    FlavorCINNAMONImprint Code N4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-8123-01 in 1 CARTON05/06/2022
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02006605/06/2022
    Labeler - Lil' Drug Store products, Inc. (093103646)