Label: NICOTAC NICOTINE POLACRILEX COATED FRUIT- nicotine gum, chewing

  • NDC Code(s): 66715-9805-5
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 10, 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 2 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, a 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.
    • 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 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 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 hiccups, heartburn, nausea, or other side effects.
    • do not use more than 24 pieces a day
    • it is important to complete treatment. If you still feel the 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 115 mg, sodium 8 mg
    • store at 20–25°C (68–77°F)
    • protect from light
  • Inactive ingredients

    acacia, acesulfame potassium, carnauba wax, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium oxide, xylitol

  • Questions or comments?

    call 1-877-440-7867

  • SPL UNCLASSIFIED SECTION

    Distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW
    Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL - 2 mg Gum Blister Pack Carton

    NICOTAC™
    NICOTINE POLACRILEX GUM USP

    2
    mg
    (nicotine)
    STOP SMOKING AID

    Coated

    Fruit Gum

    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

    Compare to the active ingredient in
    Nicorette® Fruit Chill™ Coated Gum*

    10 Pieces
    Sugar Free, 2 mg Each

    Principal Display Panel - 2 mg Gum Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    NICOTAC NICOTINE POLACRILEX  COATED FRUIT
    nicotine gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9805
    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)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    Magnesium Oxide (UNII: 3A3U0GI71G)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Sodium Carbonate (UNII: 45P3261C7T)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Xylitol (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorYELLOW (Light Yellow) Scoreno score
    ShapeSQUARESize14mm
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9805-510 in 1 CARTON10/15/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07904404/03/2018
    Labeler - Lil' Drug Store Products, Inc. (093103646)