COMMIT - nicotine lozenge 
GlaxoSmithKline Consumer Healthcare LP

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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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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

Directions 2mg Lozenge

Other information

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

This product is protected in sealed blisters.

Do not use if individual blisters or printed backings are broken, open or torn.

COMMIT®, COMMITTED 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 Original 4 mg 108 lozenge carton

Principal Display Panel

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

This product is protected in sealed blisters.

Do not use if individual blisters or printed backings are broken, open or torn.

COMMIT®, COMMITTED 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 Original 2 mg 108 lozenge carton


COMMIT 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0208
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
MAGNESIUM STEARATE 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Score no score
ShapeROUNDSize16mm
FlavorImprint Code NL2
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0135-0208-0172 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
2NDC:0135-0208-02168 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
3NDC:0135-0208-0348 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
4NDC:0135-0208-0484 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
5NDC:0135-0208-06192 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
6NDC:0135-0208-07108 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
7NDC:0135-0208-08216 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133010/31/2002

COMMIT 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0209
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
MAGNESIUM STEARATE 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Score no score
ShapeROUNDSize16mm
FlavorImprint Code NL4
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0135-0209-0172 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
2NDC:0135-0209-02168 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
3NDC:0135-0209-0348 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
4NDC:0135-0209-0484 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
5NDC:0135-0209-06192 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
6NDC:0135-0209-07108 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
7NDC:0135-0209-08216 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone
8NDC:0135-0209-0550 LOZENGE ( LOZENGE) in 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133010/31/2002

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 06/2011 GlaxoSmithKline Consumer Healthcare LP