COMMIT - nicotine lozenge 
GlaxoSmithKline Consumer Healthcare LP

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Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg

Nicotine polacrilex, 2 mg

Purpose

Stop smoking aid

Uses

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

Warnings

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 product

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.

Directions 4mg Lozenge

• 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:

• Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
  1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

• 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 fell 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.

Directions 2mg Lozenge

• 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:

• Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
  1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

• 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 fell 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.

Other information

• Each lozenge contains: sodium, 18 mg
• Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge
• store at 20 – 25oC (68 – 77oF)
• protect from light

Inactive ingredients

aspartame, calcium polycarbophil, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

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

30490IB

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in the U.K.

©2008 GlaxoSmithKline

Principal Display Panel

Commit®

Nicotine polacrilex lozenge, 4mg

STOP SMOKING AID

108 LOZENGES

4mg EACH

FROM THE MARKETERS OF NICORETTE®

Includes User’s Guide

ORIGINAL FLAVOR

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 Commit® 2mg Lozenge

• 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.

COMMIT®, COMMITED QUITTERS®, NICORETTE®, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies.

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.
2. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks.
3. Use Long Enough – Use Commit for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User’s Guide.

go to www.commitlozenge.com for online support program

Commit®

Nicotine polacrilex lozenge, 2mg

STOP SMOKING AID

108 LOZENGES

2mg EACH

FROM THE MARKETERS OF NICORETTE®

Includes User’s Guide

ORIGINAL FLAVOR

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 Commit® 4mg Lozenge

• 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.

COMMIT®, COMMITED QUITTERS®, NICORETTE®, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies.

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.
2. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks.
3. Use Long Enough  – Use Commit for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User’s Guide.

go to www.commitlozenge.com for online support program

COMMIT  nicotine polacrilex   lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0208 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 2 mg

Inactive Ingredients Ingredient Name Strength METHACRYLIC ACID-DIVINYL BENZENE COPOLYMER   ASPARTAME   CALCIUM POLYCARBOPHIL   MAGNESIUM STEARATE   MANNITOL   POTASSIUM BICARBONATE   SODIUM ALGINATE   SODIUM CARBONATE   XANTHAN GUM

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 16mm Flavor Imprint Code NL2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0208-01 72 LOZENGE In 1 BLISTER PACK None 2 0135-0208-02 168 LOZENGE In 1 BLISTER PACK None 3 0135-0208-03 48 LOZENGE In 1 BLISTER PACK None 4 0135-0208-04 84 LOZENGE In 1 BLISTER PACK None 5 0135-0208-06 192 LOZENGE In 1 BLISTER PACK None 6 0135-0208-07 108 LOZENGE In 1 BLISTER PACK None 7 0135-0208-08 216 LOZENGE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021330	10/31/2002

COMMIT  nicotine polacrilex   lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0209 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength METHACRYLIC ACID-DIVINYL BENZENE COPOLYMER   ASPARTAME   CALCIUM POLYCARBOPHIL   MAGNESIUM STEARATE   MANNITOL   POTASSIUM BICARBONATE   SODIUM ALGINATE   SODIUM CARBONATE   XANTHAN GUM

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 16mm Flavor Imprint Code NL4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0135-0209-01 72 LOZENGE In 1 BLISTER PACK None 2 0135-0209-02 168 LOZENGE In 1 BLISTER PACK None 3 0135-0209-03 48 LOZENGE In 1 BLISTER PACK None 4 0135-0209-04 84 LOZENGE In 1 BLISTER PACK None 5 0135-0209-06 192 LOZENGE In 1 BLISTER PACK None 6 0135-0209-07 108 LOZENGE In 1 BLISTER PACK None 7 0135-0209-08 216 LOZENGE In 1 BLISTER PACK None 8 0135-0209-05 50 LOZENGE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021330	10/31/2002

Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)

Revised: 01/2010GlaxoSmithKline Consumer Healthcare LP