Label: NICOTINE ORIGINAL- nicotine lozenge NICOTINE- nicotine lozenge 

  • NDC Code(s): 0363-0208-01, 0363-0208-07, 0363-0209-01, 0363-0209-07, view more
    0363-0446-02, 0363-0446-03, 0363-9170-02, 0363-9171-02, 0363-9200-02, 0363-9200-03
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

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.

    Do not use

    if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

    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

    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

    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
    before using this product, read the enclosed User’s Guide for complete directions and other important information
    stop smoking completely when you begin using the lozenge
    if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge
    if you smoke your first cigarette more than 30 minutes after waking up, use 2mg 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.
    stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.
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  • Directions (4mg Lozenge)

    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
    stop smoking completely when you begin using the lozenge
    if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge
    if you smoke your first cigarette within 30 minutes of waking up, use 4mg 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.

    stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

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  • Other information (Original)

    each lozenge contains: sodium, 18 mg
    Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge
    store at 20 – 25 oC (68 – 77 oF)
    protect from light
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  • Other Information (Cherry)

    each lozenge contains: sodium, 18mg
    store at 20 - 25 oC (68 - 77 oF)
    keep vial tightly closed and protect from light
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  • Other information (Mint)

    each lozenge contains: sodium, 18mg
    Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge
    store at 20 - 25 oC (68 - 77 oF)
    keep vial tightly closed and protect from light
    Close
  • Inactive ingredients (Original)

    aspartame, calcium polycarbophil, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

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  • Inactive ingredients (Cherry)

    acesulfame potassium, benzyl alcohol, butylhydroxy toluene, calcium polycarbophil, coconut and/or palm kernel oil, eugenol, flavors, magnesium stearate, maltodextrin, mannitol, modified corn starch, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

    Close
  • Inactive ingredients (Mint)

    acacia, aspartame, calcium polycarbophil, corn syrup solids, flavors, lactose, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, soy protein, triethyl citrate, xanthan gum

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  • Questions or comments?

    call toll-free 1-877-306-0019 (English/Spanish) weekdays (9:00 am – 4:30 pm ET)

    Distributed by: Walgreen Co.,

    200 Wilmot Rd., Deerfield, IL 60015-4616

    Quality Guaranteed 100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back.

    www.walgreens.com

    Close
  • Principal Display Panel

    NDC 0363-0209-01

    Nicotine Lozenge

    Walgreens

    Nicotine Polacrilex Lozenge, 4mg

    STOP SMOKING AID

    Original Flavor

    72 LOZENGES

    4mg EACH

    Compare to Nicorette®* Lozenge

    Includes User’s Guide

    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 Nicotine Polacrilex Lozenge, 2mg

    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

    This product is protected in sealed blisters.

    Do not use if individual blisters or printed backings are broken, open or torn.

    TO INCREASE YOUR SUCCESS IN QUITTING:

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

    To remove the lozenge, tear off single unit.

    Peel off backing starting at corner with loose edge.

    Push lozenge through foil.

    Comments/questions:

    GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

    Research Triangle Park, NC 27709-9627

    *NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

    Made in Switzerland

    ©2011

    101025XA

    Nicotine Lozenge Walgreens 4mg 72 ct carton
    Close
  • Principal Display Panel

    NDC 0363-0208-01

    Nicotine Lozenge

    Walgreens

    Nicotine Polacrilex Lozenge, 2mg

    STOP SMOKING AID

    Original Flavor

    72 LOZENGES

    2mg EACH

    Compare to Nicorette®* Lozenge

    Includes User’s Guide

    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 Lozenge, 4mg

    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

    This product is protected in sealed blisters.

    Do not use if individual blisters or printed backings are broken, open or torn.

    TO INCREASE YOUR SUCCESS IN QUITTING:

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

    To remove the lozenge, tear off single unit.

    Peel off backing starting at corner with loose edge.

    Push lozenge through foil.

    Comments/questions:

    GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

    Research Triangle Park, NC 27709-9627

    *NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

    Made in Switzerland

    ©2011

    101032XA

    Nicotine Lozenge Walgreens 2mg 72 ct carton
    Close
  • Principal Display Panel

    NDC 0363-9200-02

    Nicotine Lozenge

    Walgreens

    Nicotine Polacrilex Lozenge, 4mg

    STOP SMOKING AID

    Cherry Flavor

    72 LOZENGES, 4mg EACH (3 Vials of 24)

    Compare to Nicorette®* Lozenge

    Includes User’s Guide

    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 Nicotine Polacrilex Lozenge, 2mg

    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.

    TO INCREASE YOUR SUCCESS IN QUITTING:

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

    To open vial, push in child resistant band on the vial with thumb.

    Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

    Comments/questions:

    GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

    Research Triangle Park, NC 27709-9627

    *NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

    Made in Switzerland

    ©2011

    101157XC

    Nicotine Lozenge Walgreens Cherry 4mg 72 ct carton
    Close
  • Principal Display Panel

    NDC 0363-0446-02

    Nicotine Lozenge

    Walgreens

    Nicotine Polacrilex Lozenge, 2mg

    STOP SMOKING AID

    Cherry Flavor

    72 LOZENGES, 2mg EACH (3 Vials of 24)

    Compare to Nicorette®* Lozenge

    Includes User’s Guide

    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 Lozenge, 4mg

    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.

    TO INCREASE YOUR SUCCESS IN QUITTING:

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

    To open vial, push in child resistant band on the vial with thumb.

    Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

    Comments/questions:

    GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

    Research Triangle Park, NC 27709-9627

    *NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

    Made in Switzerland

    ©2011

    101119XB

    Nicotine Lozenge Walgreens Cherry 2mg 72 ct carton
    Close
  • Principal Display Panel

    NDC 0363-9171-02

    Nicotine Lozenge

    Walgreens

    Nicotine Polacrilex Lozenge, 4mg

    STOP SMOKING AID

    Mint Flavor

    72 LOZENGES, 4mg EACH (3 Vials of 24)

    Compare to Nicorette®* Lozenge

    Includes User’s Guide

    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 Nicotine Polacrilex Lozenge, 2mg

    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.

    TO INCREASE YOUR SUCCESS IN QUITTING:

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

    To open vial, push in child resistant band on the vial with thumb.

    Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

    Comments/questions:

    GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

    Research Triangle Park, NC 27709-9627

    *NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

    Made in Switzerland

    ©2011

    101137XA

    Nicotine Lozenge Walgreens Mint 4mg 72 ct carton
    Close
  • Principal Display Panel

    NDC 0363-9170-02

    Nicotine Lozenge

    Walgreens

    Nicotine Polacrilex Lozenge, 2mg

    STOP SMOKING AID

    Mint Flavor

    72 LOZENGES, 2mg EACH (3 Vials of 24)

    Compare to Nicorette®* Lozenge

    Includes User’s Guide

    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 Lozenge, 4mg

    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.

    TO INCREASE YOUR SUCCESS IN QUITTING:

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

    To open vial, push in child resistant band on the vial with thumb.

    Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

    Comments/questions:

    GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

    Research Triangle Park, NC 27709-9627

    *NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

    Made in Switzerland

    ©2011

    101141XA

    Nicotine Lozenge Walgreens Mint 2mg 72 ct carton
    Close
  • INGREDIENTS AND APPEARANCE
    NICOTINE  ORIGINAL
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0209
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 4 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN  
    ASPARTAME  
    CALCIUM POLYCARBOPHIL  
    MAGNESIUM STEARATE  
    MANNITOL  
    POTASSIUM BICARBONATE  
    SODIUM ALGINATE  
    SODIUM CARBONATE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 16mm
    Flavor MINT Imprint Code PL4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0209-01 6 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:0363-0209-07 9 in 1 CARTON
    2 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021330 10/31/2002
    NICOTINE  ORIGINAL
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0208
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN  
    ASPARTAME  
    CALCIUM POLYCARBOPHIL  
    MAGNESIUM STEARATE  
    MANNITOL  
    POTASSIUM BICARBONATE  
    SODIUM ALGINATE  
    SODIUM CARBONATE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 16mm
    Flavor MINT Imprint Code PL2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0208-01 6 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:0363-0208-07 9 in 1 CARTON
    2 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021330 10/31/2002
    NICOTINE 
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9200
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 4 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN  
    ACESULFAME POTASSIUM  
    BENZYL ALCOHOL  
    BUTYLATED HYDROXYTOLUENE  
    CALCIUM POLYCARBOPHIL  
    COCONUT OIL  
    PALM KERNEL OIL  
    EUGENOL  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    MANNITOL  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)  
    POTASSIUM BICARBONATE  
    SODIUM ALGINATE  
    SODIUM CARBONATE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 16mm
    Flavor CHERRY Imprint Code PL4C
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9200-02 3 in 1 CARTON
    1 24 in 1 CONTAINER
    2 NDC:0363-9200-03 4 in 1 CARTON
    2 27 in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021330 07/14/2011
    NICOTINE 
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0446
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN  
    ACESULFAME POTASSIUM  
    BENZYL ALCOHOL  
    BUTYLATED HYDROXYTOLUENE  
    CALCIUM POLYCARBOPHIL  
    COCONUT OIL  
    PALM KERNEL OIL  
    EUGENOL  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    MANNITOL  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)  
    POTASSIUM BICARBONATE  
    SODIUM ALGINATE  
    SODIUM CARBONATE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 16mm
    Flavor CHERRY Imprint Code PL2C
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0446-02 3 in 1 CARTON
    1 24 in 1 CONTAINER
    2 NDC:0363-0446-03 4 in 1 CARTON
    2 27 in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021330 07/14/2011
    NICOTINE 
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9171
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 4 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN  
    ACACIA  
    ASPARTAME  
    CALCIUM POLYCARBOPHIL  
    CORN SYRUP  
    LACTOSE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    MANNITOL  
    POTASSIUM BICARBONATE  
    SODIUM ALGINATE  
    SODIUM CARBONATE  
    SOY PROTEIN  
    TRIETHYL CITRATE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 16mm
    Flavor MINT Imprint Code PL4S
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9171-02 3 in 1 CARTON
    1 24 in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021330 07/14/2011
    NICOTINE 
    nicotine polacrilex lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9170
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLACRILIN  
    ACACIA  
    ASPARTAME  
    CALCIUM POLYCARBOPHIL  
    CORN SYRUP  
    LACTOSE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    MANNITOL  
    POTASSIUM BICARBONATE  
    SODIUM ALGINATE  
    SODIUM CARBONATE  
    SOY PROTEIN  
    TRIETHYL CITRATE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 16mm
    Flavor MINT Imprint Code PL2S
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9170-02 3 in 1 CARTON
    1 24 in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021330 07/14/2011
    Labeler - Walgreens (008965063)
    Registrant - GlaxoSmithKline Consumer Healthcare LP (828924212)
    Close