Label: NICORETTE- nicotine polacrilex lozenge

  • NDC Code(s): 0135-0635-01, 0135-0635-02, 0135-0636-01, 0135-0636-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 21, 2024

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

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

    Nicotine polacrilex, 2 mg (nicotine)

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

    Nicotine polacrilex, 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 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 (about 20 - 30 minutes). 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 (about 20 - 30 minutes)
    • 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 (about 20 - 30 minutes). 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 (about 20 - 30 minutes)
    • 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

    • each lozenge contains:sodium 17 mg
    • Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge
    • sugar alcohol content: 1 g mannitol per lozenge
    • store at 20 - 25°C (68 - 77°F)
    • keep vial tightly closed and protect from light
  • Inactive ingredients

    aspartame, magnesium stearate, mannitol, natural peppermint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, soy protein, xanthan gum

  • Questions or comments?

    call toll-free 1-888-569-1743

  • Additional Information

    • 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

    TAMPER EVIDENT FEATURE:Do not use if printed inner safety seal under cap is broken or missing.

    Retain outer carton for full product uses, directions and warnings.

    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 ®Lozenges for the full 12 weeks.
    4. Use with a support programas directed in the enclosed User’s Guide.

    Quit Tube ®

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

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

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

    ©2020 GSK group of companies or its licensor.

  • Principal Display Panel

    NDC 0135-0635-01

    Nicorette

    nicotine polacrilex lozenge, 2 mg

    stop smoking aid

    Lozenge

    Includes User’s Guide

    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 Lozenge

    Mint

    72 LOZENGES,2 mg Each

    (3 QuitTube ®Containers of 24)

    45PB9SBC1-NRO – Front Carton

    Nicorette mint lozenges 2mg 72 ct
  • Principal Display Panel

    NDC 0135-0636-01

    Nicorette

    nicotine polacrilex lozenge, 4 mg

    stop smoking aid

    Lozenge

    Includes User’s Guide

    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 Lozenge.

    Mint

    72 LOZENGES,4 mg Each

    (3 QuitTube ®Containers of 24)

    84LB9SBC1-NRO – Front Carton

    Nicorette mint lozenges 4mg 72 ct
  • INGREDIENTS AND APPEARANCE
    NICORETTE 
    nicotine polacrilex lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0635
    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)  
    ASPARTAME (UNII: Z0H242BBR1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize16mm
    FlavorMINTImprint Code L344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0635-013 in 1 CARTON06/01/2022
    172 in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0135-0635-026 in 1 CARTON06/01/2022
    2144 in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02133006/01/2022
    NICORETTE 
    nicotine polacrilex lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0636
    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)  
    ASPARTAME (UNII: Z0H242BBR1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize16mm
    FlavorMINTImprint Code L873
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0636-013 in 1 CARTON06/01/2022
    172 in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0135-0636-026 in 1 CARTON06/01/2022
    2144 in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02133006/01/2022
    Labeler - Haleon US Holdings LLC (079944263)