Label: NICORETTE- nicotine polacrilex lozenge

  • NDC Code(s): 0135-0625-01, 0135-0625-02, 0135-0625-03, 0135-0626-01, view more
    0135-0626-02, 0135-0626-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 7, 2020

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

  • Active ingredient (in each lozenge) (2 mg)

    Nicotine polacrilex, 2 mg

  • Active ingredient (in each lozenge) (4 mg)

    Nicotine polacrilex, 4 mg

  • 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

    heart disease, 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 problems occur
    persistent indigestion or severe sore throat occurs
    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.

    Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it 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. No studies have been done to show if this product will work for you.
    before using this product, read the enclosed User’s Guide for complete directions and other important information
    begin using the lozenge on your quit day
    if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge
    if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

    Weeks 1 to 6

    Weeks 7 to 9

    Weeks 10 to 12

    1 lozenge every 1 to 2 hours

    1 lozenge every 2 to 4 hours

    1 lozenge every 4 to 8 hours

    nicotine lozenge is a medicine and must be used a certain way to get the best results
    place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
    you may feel a warm or tingling sensation
    occasionally move the lozenge from one side of your mouth to the other until completely dissolved
    do not eat or drink 15 minutes before using or while the lozenge is in your mouth
    to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
    do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
    do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
    it is important to complete treatment. If you feel you need to use the lozenge 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. No studies have been done to show if this product will work for you.
    before using this product, read the enclosed User’s Guide for complete directions and other important information
    begin using the lozenge on your quit day
    if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge
    if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

    Weeks 1 to 6

    Weeks 7 to 9

    Weeks 10 to 12

    1 lozenge every 1 to 2 hours

    1 lozenge every 2 to 4 hours

    1 lozenge every 4 to 8 hours

    nicotine lozenge is a medicine and must be used a certain way to get the best results
    place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
    you may feel a warm or tingling sensation
    occasionally move the lozenge from one side of your mouth to the other until completely dissolved
    do not eat or drink 15 minutes before using or while the lozenge is in your mouth
    to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
    do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
    do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
    it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.
  • Other information (Ice Mint)

    store at 20 - 25°C (68 - 77°F)
    Store in the original container
  • Inactive ingredients (Ice Mint)

    acesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, potassium aluminum silicate, sodium carbonate, xanthan gum

  • Questions or comments?

    call toll-free 1-888-569-1743

  • Principal Display Panel

    NDC 0135-0625-02

    NEW

    Nicorette

    nicotine polacrilex lozenge, 2 mg •stop smoking aid

    Lozenge

    Coated

    Ice Mint

    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 Nicorette 4mg Lozenge.

    2 mg

    80 LOZENGES, 2mg EACH

    (4 Packs of 20)

    Includes User’s Guide

    TO INCREASE YOUR SUCCESS IN QUITTING:

    1.
    You must be motivated to quit.
    2.
    Use Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
    3.
    Use Long Enough - Use Nicorette for the full 12 weeks.
    4.
    Use With a Support Program as directed in the enclosed User’s Guide.

    For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.

    TO OPEN

    PUSH

    LIFT

    TO CLOSE

    Push Cap Closed until you hear a CLICK to ensure child resistance

    CLICK

    Distributed By:

    GlaxoSmithKline Consumer Healthcare

    Warren, NJ 07059

    Made in the Switzerland

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2018 GSK group of companies or its licensor.

    106600XA

    106600XA_Nicorette Ice Mint_2 mg_80 Lozenges.JPG
  • Principal Display Panel

    NDC 0135-0626-02

    NEW

    Nicorette

    nicotine polacrilex lozenge, 4 mg •stop smoking aid

    Lozenge

    Coated Ice Mint

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

    If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2 mg Lozenge.

    4 mg

    80 LOZENGES, 2mg EACH

    (4 Packs of 20)

    Includes User’s Guide

    TO INCREASE YOUR SUCCESS IN QUITTING:

    1.
    You must be motivated to quit.
    2.
    Use Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
    3.
    Use Long Enough - Use Nicorette for the full 12 weeks.
    4.
    Use With a Support Program as directed in the enclosed User’s Guide.

    For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.

    TO OPEN

    PUSH

    LIFT

    TO CLOSE

    Push Cap Closed until you hear a CLICK to ensure child resistance

    CLICK

    Distributed By:

    GlaxoSmithKline Consumer Healthcare

    Warren, NJ 07059

    Made in the Switzerland

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2018 GSK group of companies or its licensor.

    106608XA

    106608XA_Nicorette Ice Mint_4 mg_80 Lozenges.JPG
  • INGREDIENTS AND APPEARANCE
    NICORETTE 
    nicotine polacrilex lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0625
    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)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM (UNII: RWP5GA015D)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVALSize15mm
    FlavorMINT (Ice Mint) Imprint Code n;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0625-011 in 1 CARTON04/11/2019
    120 in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0135-0625-024 in 1 CARTON04/11/2019
    220 in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:0135-0625-036 in 1 CARTON10/23/2019
    320 in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02133004/11/2019
    NICORETTE 
    nicotine polacrilex lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0626
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM (UNII: RWP5GA015D)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVALSize15mm
    FlavorMINT (Ice Mint) Imprint Code n;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0626-011 in 1 CARTON04/11/2019
    120 in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0135-0626-024 in 1 CARTON04/11/2019
    220 in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:0135-0626-036 in 1 CARTON10/23/2019
    320 in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02133004/11/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)