Nicorette Lozenge: Package Insert / Prescribing Info

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.

Other information

•

store at 20 – 25oC (68 – 77oF)

•

keep vial tightly closed and protect from light

Inactive ingredients

acesulfame potassium, calcium polycarbophil, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan gum

Questions or comments?

call toll-free 1-888-569-1743

Additional Information

TO INCREASE YOUR SUCCESS IN QUITTING:

1.

You must be motivated to quit.

2.

Use Enough – Use at least 9 Nicorette mini Lozenges per day during the first six weeks.

3.

Use Long Enough – Use Nicorette mini Lozenges for the full 12 weeks.

4.

Use with a support program as directed in the enclosed User’s Guide.

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.

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

Opening Directions:

Squeeze child resistant tabs on each side. Flup up the top of vial. Turn upside down and shake to remove lozenge.

Principal Display Panel

NDC 0135-2800-02

NICORETTE

nicotine polacrilex lozenge, 2 mg

stop smoking aid

mini Lozenge

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 Nicorette4 mg Lozenge.

NEW VIAL & OPENING DIRECTIONS

81 LOZENGES, 2 mg EACH

(3 Vials of 27)

Mint

Principal Display Panel

NDC 0135-1500-02

NICORETTE

nicotine polacrilex lozenge, 4 mg

stop smoking aid

mini Lozenge

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 Nicorette2 mg Lozenge.

NEW VIAL & OPENING DIRECTIONS

81 LOZENGES, 4 mg EACH

(3 Vials of 27)

Mint