Nicorette Lozenge Prescribing Information

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

Indications and Usage for Nicorette Lozenge

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

Warnings

Nicorette Lozenge Dosage and Administration

• 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:

• 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. 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
• 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.

Nicorette Lozenge Dosage and Administration

• 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:

• 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. 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
• 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.

Storage and Handling

• store at 20 - 25°C (68 - 77°F)
• Store in the original container

Inactive ingredients (Ice Mint)

acesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, potassium aluminum silicate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-888-569-1743

Principal Display Panel

NDC 0135-0625-02

NEW

Nicorette

nicotine polacrilex lozenge, 2 mg •stop smoking aid

Lozenge

Coated

Ice Mint

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.

2 mg

80 LOZENGES, 2mg EACH

(4 Packs of 20)

Includes User’s Guide

TO INCREASE YOUR SUCCESS IN QUITTING:

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

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

TO OPEN

PUSH

LIFT

TO CLOSE

Push Cap Closeduntil you hear a CLICK to ensure child resistance

CLICK

Distributed By:

GlaxoSmithKline Consumer Healthcare

Warren, NJ 07059

Made in the Switzerland

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

©2018 GSK group of companies or its licensor.

106600XA

Principal Display Panel

NDC 0135-0626-02

NEW

Nicorette

nicotine polacrilex lozenge, 4 mg •stop smoking aid

Lozenge

Coated Ice Mint

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Lozenge.

4 mg

80 LOZENGES, 2mg EACH

(4 Packs of 20)

Includes User’s Guide

TO INCREASE YOUR SUCCESS IN QUITTING:

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

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

TO OPEN

PUSH

LIFT

TO CLOSE

Push Cap Closeduntil you hear a CLICK to ensure child resistance

CLICK

Distributed By:

GlaxoSmithKline Consumer Healthcare

Warren, NJ 07059

Made in the Switzerland

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

©2018 GSK group of companies or its licensor.

106608XA