NICORETTE

GlaxoSmithKline Consumer Healthcare LP

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

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FULL PRESCRIBING INFORMATION

Nicotine polacrilex, 4 mg

Nicotine polacrilex, 2 mg

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

• •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
• •begin using the lozenge on your quit day
• • 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. 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.

• • 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 lozenge on your quit day
• • 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. 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.

• • each lozenge contains: sodium, 5 mg
• •store at 20 – 25^oC (68 – 77^oF)
• •keep vial tightly closed and protect from light

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

call toll-free 1-888-569-1743 (English/Spanish) weekdays (9:00 am – 4:30 pm ET)

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

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the Switzerland

Opening Directions:

Push in child resistant tab on the vial with thumb.

Flip up the top of vial. Turn upside down and shake to remove lozenge.

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.

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NDC 0135-0509-02

Nicorette^®

Nicotine polacrilex lozenge, 4mg

stop smoking aid

mini Lozenge

Mint

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

81 LOZENGES, 4mg Each

(3 Vials of 27)

NEW DIRECTIONS FOR USE

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

©2013 GlaxoSmithKline

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