Nicotine

Kroger Company
GlaxoSmithKline Consumer Healthcare LP

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

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FULL PRESCRIBING INFORMATION

Nicotine polacrilex, 2mg

Nicotine polacrilex, 4mg

Stop smoking aid

• •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

• •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.

• • 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:

• • 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.

• • 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:

• • 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.

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

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

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

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

call toll-free 1-800-491-1830 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)

• • not for sale to those under 18 years of age
• • proof of age required
• • not for sale in vending machines or 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.

*Nicorette® is a registered trademark of the GlaxoSmithKline group of companies, Wilmington, DE 19808. GlaxoSmithKline group of companies is not affiliated with The Kroger Co.

Made in Switzerland.

Distributed by

The Kroger Company

Cincinnati, Ohio 45202

QUALITY GUARANTEED

If you are not completely satisfied with this product, return it for a refund or replacement.

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 NDC 30142-863-01

Nicotine Lozenge

nicotine polacrilex lozenge, 2mg

STOP SMOKING AID

Kroger _®

QUALITY GUARANTEED

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

72 LOZENGES 2 mg each (3 vials of 24)

CHERRY FLAVOR

*Compare to Active Ingredient of Nicorette^® Lozenge. See Back Panel.

Convenient Carrying Case

©2011

101524XA