Nicotineoriginal lozenge

Active ingredient (in each lozenge) 2mg

Nicotine polacrilex, 2 mg

Active ingredient (in each lozenge) 4mg

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.

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.

Directions (2mg lozenge )

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed Users 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.

Directions (4mg lozenge)

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed Users 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.

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

Other information (cherry)

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

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

Inactive ingredients (original)

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

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

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

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

Ingredients and appearance - Product information

Nicotineoriginal lozenge- Nicotine polacrilex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-0209
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nicotine ( UNII: 6M3C89ZY6R)( Nicotine - UNII: 6M3C89ZY6R ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
Polacrilin ( UNII: RCZ785HI7S)
Aspartame ( UNII: Z0H242BBR1)
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) Size 16 mm
Shape ROUND Score 1
Imprint Code PL4 Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021330 USA

Nicotineoriginal lozenge- Nicotine polacrilex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-0208
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nicotine ( UNII: 6M3C89ZY6R)( Nicotine - UNII: 6M3C89ZY6R ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Polacrilin ( UNII: RCZ785HI7S)
Aspartame ( UNII: Z0H242BBR1)
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) Size 16 mm
Shape ROUND Score 1
Imprint Code PL2 Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021330 USA

Nicotine lozenge- Nicotine polacrilex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-9200
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nicotine ( UNII: 6M3C89ZY6R)( Nicotine - UNII: 6M3C89ZY6R ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
Polacrilin ( UNII: RCZ785HI7S)
Acesulfame potassium ( UNII: 23OV73Q5G9)
Benzyl alcohol ( UNII: LKG8494WBH)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Calcium polycarbophil ( UNII: 8F049NKY49)
Coconut oil ( UNII: Q9L0O73W7L)
Palm kernel oil ( UNII: B0S90M0233)
Eugenol ( UNII: 3T8H1794QW)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Mannitol ( UNII: 3OWL53L36A)
Modified corn starch (1-octenyl succinic anhydride) ( UNII: 461P5CJN6T)
Potassium bicarbonate ( UNII: HM5Z15LEBN)
Sodium alginate ( UNII: C269C4G2ZQ)
Sodium carbonate ( UNII: 45P3261C7T)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE (white to off-white) Size 16 mm
Shape ROUND Score 1
Imprint Code PL4C Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021330 USA

Nicotine lozenge- Nicotine polacrilex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-0446
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nicotine ( UNII: 6M3C89ZY6R)( Nicotine - UNII: 6M3C89ZY6R ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Polacrilin ( UNII: RCZ785HI7S)
Acesulfame potassium ( UNII: 23OV73Q5G9)
Benzyl alcohol ( UNII: LKG8494WBH)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Calcium polycarbophil ( UNII: 8F049NKY49)
Coconut oil ( UNII: Q9L0O73W7L)
Palm kernel oil ( UNII: B0S90M0233)
Eugenol ( UNII: 3T8H1794QW)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Mannitol ( UNII: 3OWL53L36A)
Modified corn starch (1-octenyl succinic anhydride) ( UNII: 461P5CJN6T)
Potassium bicarbonate ( UNII: HM5Z15LEBN)
Sodium alginate ( UNII: C269C4G2ZQ)
Sodium carbonate ( UNII: 45P3261C7T)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE (white to off-white) Size 16 mm
Shape ROUND Score 1
Imprint Code PL2C Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021330 USA

Nicotine lozenge- Nicotine polacrilex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-9171
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nicotine ( UNII: 6M3C89ZY6R)( Nicotine - UNII: 6M3C89ZY6R ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
Polacrilin ( UNII: RCZ785HI7S)
Acacia ( UNII: 5C5403N26O)
Aspartame ( UNII: Z0H242BBR1)
Calcium polycarbophil ( UNII: 8F049NKY49)
Corn syrup ( UNII: 9G5L16BK6N)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Mannitol ( UNII: 3OWL53L36A)
Potassium bicarbonate ( UNII: HM5Z15LEBN)
Sodium alginate ( UNII: C269C4G2ZQ)
Sodium carbonate ( UNII: 45P3261C7T)
Soy protein ( UNII: R44IWB3RN5)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE (white to off-white) Size 16 mm
Shape ROUND Score 1
Imprint Code PL4S Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021330 USA

Nicotine lozenge- Nicotine polacrilex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-9170
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Nicotine ( UNII: 6M3C89ZY6R)( Nicotine - UNII: 6M3C89ZY6R ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Polacrilin ( UNII: RCZ785HI7S)
Acacia ( UNII: 5C5403N26O)
Aspartame ( UNII: Z0H242BBR1)
Calcium polycarbophil ( UNII: 8F049NKY49)
Corn syrup ( UNII: 9G5L16BK6N)
Lactose, unspecified form ( UNII: J2B2A4N98G)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Mannitol ( UNII: 3OWL53L36A)
Potassium bicarbonate ( UNII: HM5Z15LEBN)
Sodium alginate ( UNII: C269C4G2ZQ)
Sodium carbonate ( UNII: 45P3261C7T)
Soy protein ( UNII: R44IWB3RN5)
Triethyl citrate ( UNII: 8Z96QXD6UM)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color WHITE (white to off-white) Size 16 mm
Shape ROUND Score 1
Imprint Code PL2S Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021330 USA

Labeler - Walgreens( 008965063)

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 Users Guide

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 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:

  • You must be motivated to quit.
  • Use EnoughUse at least 9 lozengesper day during the first six weeks.
  • Use Long EnoughUse for the full 12 weeks.
  • Use With a Support Programas directed in the enclosed Users 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

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 Users Guide

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 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:

  • You must be motivated to quit.
  • Use EnoughUse at least 9 lozengesper day during the first six weeks.
  • Use Long EnoughUse for the full 12 weeks.
  • Use With a Support Programas directed in the enclosed Users 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

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 Users Guide

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 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:

  • You must be motivated to quit.
  • Use EnoughUse at least 9 lozengesper day during the first six weeks.
  • Use Long EnoughUse for the full 12 weeks.
  • Use With a Support Programas directed in the enclosed Users 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

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 Users Guide

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 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:

  • You must be motivated to quit.
  • Use EnoughUse at least 9 lozengesper day during the first six weeks.
  • Use Long EnoughUse for the full 12 weeks.
  • Use With a Support Programas directed in the enclosed Users 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

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 Users Guide

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 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:

  • You must be motivated to quit.
  • Use EnoughUse at least 9 lozengesper day during the first six weeks.
  • Use Long EnoughUse for the full 12 weeks.
  • Use With a Support Programas directed in the enclosed Users 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

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 Users Guide

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 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:

  • You must be motivated to quit.
  • Use EnoughUse at least 9 lozengesper day during the first six weeks.
  • Use Long EnoughUse for the full 12 weeks.
  • Use With a Support Programas directed in the enclosed Users 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