Label: NICORETTE- nicotine polacrilex lozenge

  • NDC Code(s): 0135-0508-02, 0135-0508-03, 0135-0508-04, 0135-0509-02, view more
    0135-0509-03, 0135-0509-04
  • 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 9, 2016

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

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

    Nicotine polacrilex, 2 mg

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

    Nicotine polacrilex, 4 mg

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  • Purpose

    Stop smoking aid

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  • Use

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

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  • Directions (2mg Lozenge)

    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 1to 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.
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  • Directions (4mg Lozenge)

    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 1to 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.
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  • Other information

    each lozenge contains: sodium, 5 mg
    store at 20 – 25 oC (68 – 77 oF)
    keep vial tightly closed and protect from light
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  • Inactive ingredients

    acesulfame potassium, calcium polycarbophil, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

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  • Questions or comments?

    call toll-free 1-888-569-1743

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  • Principal Display Panel

    NDC 0135-0508-02

    Nicorette®

    nicotine polacrilex lozenge, 2mg

    stop smoking aid

    mini Lozenge

    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®  4 mg Lozenge

    81 LOZENGES, 2 mg Each

    (3 Vials of 27)

    Opening Directions:

    Push in child resistant tab on the vial with thumb.

    Flip up the top of vial. Turn upside down and shake to remove lozenge.

    TO INCREASE YOUR SUCCESS IN QUITTING:

    1.
    You must be motivated to quit.
    2.
    Use Enough – Use at least 9 Nicorette ® mini lozenges per day during the first six weeks.
    3.
    Use Long Enough – Use Nicorette ® mini lozenges for the full 12 weeks.
    4.
    Use With a Support Program as directed in the enclosed User’s Guide.
    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 clear neckband printed "SEALED FOR SAFETY" is missing or broken. Retain outer carton for full product uses, directions and warnings.

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

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

    Distributed By:

    GSK Consumer Healthcare

    Warren, NJ 07059

    Made in the Switzerland

    ©2015 GSK group of companies or its licensor. All rights reserved.

    104277XB

    Nicorette Mini Lozenge 2 mg 81 ct carton
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  • Principal Display Panel

    NDC 0135-0509-02

    Nicorette®

    nicotine polacrilex lozenge, 4mg

    stop smoking aid

    mini Lozenge

    Mint

    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 Lozenge

    81 LOZENGES, 4 mg Each

    (3 Vials of 27)

    Opening Directions:

    Push in child resistant tab on the vial with thumb.

    Flip up the top of vial. Turn upside down and shake to remove lozenge.

    TO INCREASE YOUR SUCCESS IN QUITTING:

    1.
    You must be motivated to quit.
    2.
    Use Enough – Use at least 9 Nicorette ® mini lozenges per day during the first six weeks.
    3.
    Use Long Enough – Use Nicorette ® mini lozenges for the full 12 weeks.
    4.
    Use With a Support Program as directed in the enclosed User’s Guide.
    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 clear neckband printed "SEALED FOR SAFETY" is missing or broken. Retain outer carton for full product uses, directions and warnings.

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

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

    Distributed By:

    GSK Consumer Healthcare

    Warren, NJ 07059

    Made in the Switzerland

    ©2015 GSK group of companies or its licensor. All rights reserved.

    104255XB

    Nicorette Mini Lozenge 4 mg 81 ct carton
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  • INGREDIENTS AND APPEARANCE
    NICORETTE 
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0508
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN (UNII: RCZ785HI7S)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)  
    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
    Color WHITE (white to off-white) Score no score
    Shape OVAL Size 10mm
    Flavor MINT Imprint Code M
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0508-02 3 in 1 CARTON 03/01/2010
    1 27 in 1 CONTAINER; Type 0: Not a Combination Product
    2 NDC:0135-0508-03 5 in 1 CARTON 03/01/2010
    2 27 in 1 CONTAINER; Type 0: Not a Combination Product
    3 NDC:0135-0508-04 20 in 1 CONTAINER; Type 0: Not a Combination Product 03/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022360 03/01/2010
    NICORETTE 
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0509
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 4 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN (UNII: RCZ785HI7S)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)  
    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
    Color WHITE (white to off-white) Score no score
    Shape OVAL Size 10mm
    Flavor MINT Imprint Code F
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0509-02 3 in 1 CARTON 03/01/2010
    1 27 in 1 CONTAINER; Type 0: Not a Combination Product
    2 NDC:0135-0509-03 5 in 1 CARTON 03/01/2010
    2 27 in 1 CONTAINER; Type 0: Not a Combination Product
    3 NDC:0135-0509-04 20 in 1 CONTAINER; Type 0: Not a Combination Product 03/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022360 03/01/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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