Your browser does not support JavaScript! NICOTINE ORIGINAL (NICOTINE POLACRILEX) LOZENGE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]
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NICOTINE ORIGINAL (nicotine polacrilex) lozenge
NICOTINE (nicotine polacrilex) lozenge
[Walgreens]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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 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.

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.

Other information (Original)

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

Other Information (Cherry)

each lozenge contains: sodium, 18mg
store at 20 - 25oC (68 - 77oF)
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 - 25oC (68 - 77oF)
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

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

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

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

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

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

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
NICOTINE  ORIGINAL
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0209
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
MAGNESIUM STEARATE 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code PL4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0209-016 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:0363-0209-079 in 1 CARTON
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133010/31/2002
NICOTINE  ORIGINAL
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0208
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
MAGNESIUM STEARATE 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code PL2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0208-016 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:0363-0208-079 in 1 CARTON
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133010/31/2002
NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-9200
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code PL4C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9200-023 in 1 CARTON
124 in 1 CONTAINER
2NDC:0363-9200-034 in 1 CARTON
227 in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133007/14/2011
NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0446
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code PL2C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0446-023 in 1 CARTON
124 in 1 CONTAINER
2NDC:0363-0446-034 in 1 CARTON
227 in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133007/14/2011
NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-9171
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code PL4S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9171-023 in 1 CARTON
124 in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133007/14/2011
NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-9170
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code PL2S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9170-023 in 1 CARTON
124 in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133007/14/2011
Labeler - Walgreens (008965063)
Registrant - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 11/2013
 
Walgreens

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