Nicorette

GlaxoSmithKline Consumer Healthcare LP

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

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FULL PRESCRIBING INFORMATION

Nicotine polacrilex (equal to 2mg nicotine)

Nicotine polacrilex (equal to 4mg nicotine)

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.

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 blood pressure.
• •stomach ulcer or diabetes

Ask a doctor or a 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, teeth or jaw problems occur
• •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.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum 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
• •begin using the gum on your quit day
• • if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine gum
• • if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine gum according to the following 12 week schedule:

• •nicotine gum is a medicine and must be used a certain way to get the best results
• •chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
• •repeat this process until most of the tingle is gone (about 30 minutes)
• •do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
• •to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
• •if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
• •do not use more than 24 pieces a day
• •it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

• • 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
• •begin using the gum on your quit day
• • if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine gum
• • if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine gum according to the following 12 week schedule:

• •nicotine gum is a medicine and must be used a certain way to get the best results
• •chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
• •repeat this process until most of the tingle is gone (about 30 minutes)
• •do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
• •to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
• •if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
• •do not use more than 24 pieces a day
• •it is important to complete treatment. If you feel you need to sue the gum for a longer period to keep from smoking, talk to your health care provider.

• • (2 mg) each piece contains: calcium 94 mg, sodium 11 mg
• • (4 mg) each piece contains: calcium 94 mg, sodium 13 mg
• •store at 20 -25^oC (68 - 77^oF)
• •protect from light

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

call toll-free 1-800-419-4766 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)

TO INCREASE YOUR SUCCESS IN QUITTING:

• 1.You must be motivated to quit.
• 2. Use Enough – Chew at least 9 pieces of Nicorette gum per day during the first six weeks.
• 3. Use Long Enough – Use Nicorette gum for the full 12 weeks.
• 4. Use with a support program as directed in the enclosed User’s Guide.

To remove the gum, tear off single unit.

Peel off backing, starting at corner with loose edge.

Push gum through foil.

• •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.

Distributed by

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Sweden

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

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

Free Audio CD upon request. See inside.

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NDC 0135-0241-05

Nicorette^®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fruit Chill™

2 mg

NEW DIRECTIONS FOR USE

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

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 Gum

160 PIECES, 2mg EACH

©2013 GlaxoSmithKline

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