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Name:Nicorette
Manufacturer:Glaxosmithkline Consumer Healthcare Lp
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NICORETTE - nicotine lozenge 
GlaxoSmithKline Consumer Healthcare LP

----------

Drug Facts

Active ingredient (2mg)

Nicotine polacrilex, 2mg

Active ingredient (4mg)

Nicotine polacrilex, 4mg

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)

  • 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)

  • 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, 18mg
  • Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge
  • store at 20 - 25°C (68 - 77°F)
  • protect from light

NICORETTE®, COMMIT® and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to the GlaxoSmithKline group of companies.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in the U.K.

©2010 GlaxoSmithKline

  • 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 of Nicorette per day during the first six weeks.
  3. Use Long Enough - Use Nicorette for the full 12 weeks.
  4. Use With a Support Program as directed in the enclosed User’s Guide.

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

(2mg) 30743XA

(4mg) 30744XA

Other information (Mint)

  • each lozenge contains: sodium, 18mg
  • Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge
  • store at 20 - 25°C (68 - 77°F)
  • keep POPPAC tightly closed and protect from light

NICORETTE®, POPPAC ™, COMMIT® and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to the GlaxoSmithKline group of companies.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in the U.K.

©2010 GlaxoSmithKline

  • 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 of Nicorette per day during the first six weeks.
  3. Use Long Enough - Use Nicorette for the full 12 weeks.
  4. Use With a Support Program as directed in the enclosed User’s Guide.

Nicorette®

To open vial, push in child

resistant band on the POPPAC

with thumb.

POPPAC™

Flip up the top of the POPPAC and

remove lozenge. A small amount of

powder on opening of the POPPAC

is normal.

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

(2mg) 30741XA

(4mg) 30472XA

Other information (Cherry)

  • each lozenge contains: sodium, 18mg
  • store at 20 - 25°C (68 - 77°F)
  • keep POPPAC tightly closed and protect from light

NICORETTE®, POPPAC ™, COMMIT® and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to the GlaxoSmithKline group of companies.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in the U.K.

©2010 GlaxoSmithKline

  • 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 of Nicorette per day during the first six weeks.
  3. Use Long Enough - Use Nicorette for the full 12 weeks.
  4. Use With a Support Program as directed in the enclosed User’s Guide.

Nicorette®

To open vial, push in child

resistant band on the POPPAC

with thumb.

POPPAC™

Flip up the top of the POPPAC and

remove lozenge. A small amount of

powder on opening of the POPPAC

is normal.

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

(2mg) 30747XA

(4mg) 30748XA

Inactive ingredients (Original)

aspartame, calcium polycarbophil, flavor, magnesium stearate, mannitol, 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

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

Questions or comments?

call toll-free 1-888-569-1743 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)

Principal Display Panel

PREVIOUSLY

Commit®

Nicorette®

nicotine polacrilex lozenge, 2mg stop smoking aid

Lozenge

Includes User’s Guide

2mg

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 4mg Lozenge

Original

108 Lozenges, 2mg Each

Nicorette Lozenge 2mg Original Carton

Principal Display Panel

PREVIOUSLY

Commit®

Nicorette®

nicotine polacrilex lozenge, 4mg stop smoking aid

Lozenge

Includes User’s Guide

4mg

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 2mg Lozenge

Original

108 Lozenges, 4mg Each

Nicorette Lozenge 4mg Carton

Principal Display Panel

PREVIOUSLY

Commit®

Nicorette®

nicotine polacrilex lozenge, 2mg stop smoking aid

Lozenge

Includes User’s Guide

2mg

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 4mg Lozenge

Mint

72 Lozenges, 2mg Each

(3 Poppac™ Containers of 24)

Nicorette Lozenge Mint 2mg Carton

Principal Display Panel

PREVIOUSLY

Commit®

Nicorette®

nicotine polacrilex lozenge, 4mg stop smoking aid

Lozenge

Includes User’s Guide

4mg

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 2mg Lozenge

Mint

72 Lozenges, 4mg Each

(3 Poppac™ Containers of 24)

Nicorette Lozenge 4mg Mint Carton

Principal Display Panel

PREVIOUSLY

Commit®

Nicorette®

nicotine polacrilex lozenge, 2mg stop smoking aid

Lozenge

Includes User’s Guide

2mg

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 4mg Lozenge

Cherry

72 Lozenges, 2mg Each

(3 Poppac™ Containers of 24)

Nicorette Lozenge Cherry 2mg

Principal Display Panel

PREVIOUSLY

Commit®

Nicorette®

nicotine polacrilex lozenge, 4mg stop smoking aid

Lozenge

Includes User’s Guide

4mg

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 2mg Lozenge

Cherry

72 Lozenges, 4mg Each

(3 Poppac™ Containers of 24)

Nicorette Lozenge 4mg Cherry Carton


NICORETTE 
nicotine polacrilex lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0512
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 NL2C
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0512-01 72 LOZENGE ( LOZENGE) in 1 CONTAINER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/19/2010

NICORETTE 
nicotine polacrilex lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0513
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 NL4C
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0513-01 72 LOZENGE ( LOZENGE) in 1 CONTAINER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/19/2010

NICORETTE 
nicotine polacrilex lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0510
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 NL2S
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0510-01 3 CONTAINER ( CONTAINER) in 1 CARTON contains a CONTAINER
1 24 LOZENGE ( LOZENGE) in 1 CONTAINER This package is contained within the CARTON (0135-0510-01)
2 NDC:0135-0510-02 7 CONTAINER ( CONTAINER) in 1 CARTON contains a CONTAINER
2 24 LOZENGE ( LOZENGE) in 1 CONTAINER This package is contained within the CARTON (0135-0510-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/19/2010

NICORETTE 
nicotine polacrilex lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0511
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 NL4S
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0511-01 3 CONTAINER ( CONTAINER) in 1 CARTON contains a CONTAINER
1 24 LOZENGE ( LOZENGE) in 1 CONTAINER This package is contained within the CARTON (0135-0511-01)
2 NDC:0135-0511-02 7 CONTAINER ( CONTAINER) in 1 CARTON contains a CONTAINER
2 24 LOZENGE ( LOZENGE) in 1 CONTAINER This package is contained within the CARTON (0135-0511-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/19/2010

NICORETTE 
nicotine polacrilex lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0514
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 Imprint Code NL2
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0514-03 108 LOZENGE ( LOZENGE) in 1 CONTAINER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/19/2010

NICORETTE 
nicotine polacrilex lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0515
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 Imprint Code NL4
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0515-03 108 LOZENGE ( LOZENGE) in 1 CONTAINER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/19/2010

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 01/2011 GlaxoSmithKline Consumer Healthcare LP



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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