FDA Label for Nicorette

View Indications, Usage & Precautions

Nicorette Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Lozenge) (2 Mg)

Nicotine polacrilex, 2 mg

Active Ingredient (In Each Lozenge) (4 Mg)

Nicotine polacrilex, 4 mg

Purpose

Stop smoking aid

Use

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

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 (Mint)

•if you are allergic to soya

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
•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.

Directions (2 Mg)

•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 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.
•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.

Directions (4 Mg)

•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 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.
•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.

Other Information (Original)

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

Other Information (Mint)

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

Other Information (Cherry)

•each lozenge contains: sodium, 18mg
•store at 20 - 25°C (68 - 77°F)
•keep POPPAC 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 (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

Principal Display Panel

NDC 0135-0514-03

Nicorette^®

nicotine polacrilex lozenge, 2 mg

stop smoking aid

Lozenge

NEW DIRECTIONS FOR USE

•Keep Using if You Slip Up and Have a Cigarette
•Use Beyond 12 Weeks if Needed to Quit

Includes User’s Guide

2 mg

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 4mg Lozenge

Original

108 Lozenges, 2mg Each

•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 Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
•Use Long Enough - Use Nicorette for the full 12 weeks.
•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.

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

NICORETTE, and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the Switzerland

30743XC

NDC 0135-0515-03

Nicorette^®

nicotine polacrilex lozenge, 4mg

stop smoking aid

Lozenge

NEW DIRECTIONS FOR USE

•Keep Using if You Slip Up and Have a Cigarette
•Use Beyond 12 Weeks if Needed to Quit

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 THAN 30 MINUTES after waking up, use Nicorette 2mg Lozenge

Original

108 Lozenges, 4mg Each

•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 Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
•Use Long Enough - Use Nicorette for the full 12 weeks.
•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.

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

NICORETTE, and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the Switzerland

30744XC

NDC 0135-0510-07

Nicorette^®

nicotine polacrilex lozenge, 2 mg

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 WITHIN 30 MINUTES of waking up, use Nicorette 4 mg Lozenge

Mint

144 Lozenges, 2 mg Each

(6 POPPAC^® Containers of 24)

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

Nicorette^® POPPAC^®

To open vial, push in child resistant band on the POPPAC^® container with thumb.

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.

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

Distributed By:

GSK Consumer Healthcare

Warren, NJ 07059

Made in Switzerland

Made in the Switzerland

104959XC

NDC 0135-0511-07

Nicorette^®

nicotine polacrilex lozenge, 4 mg

stop smoking aid

Lozenge

Includes User’s Guide

4 mg

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

Mint

144 Lozenges, 4 mg Each

(6 POPPAC^® Containers of 24)

•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 Nicorette^®Lozenges 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^® POPPAC^®

To open vial, push in child resistant band on the POPPAC^® container with thumb.

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.

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

Distributed By:

GSK Consumer Healthcare

Warren, NJ 07059

Made in the Switzerland

104960XC

NDC 0135-0512-01

Nicorette^®

nicotine polacrilex lozenge, 2mg

stop smoking aid

Lozenge

NEW DIRECTIONS FOR USE

•Keep Using if You Slip Up and Have a Cigarette
•Use Beyond 12 Weeks if Needed to Quit

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 WITHIN 30 MINUTES of waking up, use Nicorette 4mg Lozenge

Cherry

72 Lozenges, 2mg Each

(3 Poppac^® Containers of 24)

•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 Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
•Use Long Enough - Use Nicorette for the full 12 weeks.
•Use With a Support Program as directed in the enclosed User’s Guide.

Nicorette^® POPPAC^®

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

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

NICORETTE, POPPAC and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Switzerland

30747XC

NDC 0135-0513-01

Nicorette^®

nicotine polacrilex lozenge, 4mg

stop smoking aid

Lozenge

NEW DIRECTIONS FOR USE

•Keep Using if You Slip Up and Have a Cigarette
•Use Beyond 12 Weeks if Needed to Quit

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 THAN 30 MINUTES after waking up, use Nicorette 2mg Lozenge

Cherry

72 Lozenges, 4mg Each

(3 Poppac^® Containers of 24)

•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 Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
•Use Long Enough - Use Nicorette for the full 12 weeks.
•Use With a Support Program as directed in the enclosed User’s Guide.

Nicorette^® POPPAC^®

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

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

NICORETTE, POPPAC and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Switzerland

30748XC

* Please review the disclaimer below.

Table of Contents

Nicorette Product Label

Active Ingredient (In Each Lozenge) (2 Mg)

Active Ingredient (In Each Lozenge) (4 Mg)

Purpose

Use

If You Are Pregnant Or Breast-Feeding, Only Use This Medicine On The Advice Of Your Health Care Provider.

Do Not Use (Mint)

Ask A Doctor Before Use If You Have

Ask A Doctor Or Pharmacist Before Use If You Are

Stop Use And Ask A Doctor If

Keep Out Of Reach Of Children And Pets.

Directions (2 Mg)

Directions (4 Mg)

Other Information (Original)

Other Information (Mint)

Other Information (Cherry)

Inactive Ingredients (Original)

Inactive Ingredients (Mint)

Inactive Ingredients (Cherry)

Questions Or Comments?

Principal Display Panel