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

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

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

Questions or comments?

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

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

72 LOZENGES

(3 PoppacTM Containers of 24)

4mg EACH

FROM THE MARKETERS OF NICORETTE®

Includes User’s Guide

MINT 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

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.

COMMIT®, COMMITTED QUITTERS®, POPPACTM, 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.

Commit® POPPACTM

To open vial, push in child resistant band on the POPPACTM with thumb.

Flip up the top of the POPPACTM and remove lozenge. A small amount of powder on opening of the POPPACTM is normal.

go to www.commitlozenge.com for online support program

Commit Mint 4mg Carton

Principal Display Panel

Commit®

Nicotine polacrilex lozenge, 2mg

STOP SMOKING AID

72 LOZENGES

(3 PoppacTM Containers of 24)

2mg EACH

FROM THE MARKETERS OF NICORETTE®

Includes User’s Guide

MINT 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

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.

COMMIT®, COMMITTED QUITTERS®, POPPACTM, 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.

Commit® POPPACTM

To open vial, push in child resistant band on the POPPACTM with thumb.

Flip up the top of the POPPACTM and remove lozenge. A small amount of powder on opening of the POPPACTM is normal.

go to www.commitlozenge.com for online support program

Commit Mint 2mg Carton


COMMIT 
nicotine   lozenge
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0446
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID-DIVINYL BENZENE COPOLYMER 
ACACIA 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
CORN SYRUP 
LACTOSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
SOY PROTEIN 
TRIETHYL CITRATE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Score no score
ShapeROUNDSize16mm
FlavorMINTImprint Code NL2S
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0446-0148 LOZENGE In 1 CONTAINERNone
20135-0446-0272 LOZENGE In 1 CONTAINERNone
30135-0446-03168 LOZENGE In 1 CONTAINERNone
40135-0446-07144 LOZENGE In 1 CONTAINERNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133002/13/2004

COMMIT 
nicotine   lozenge
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0447
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID-DIVINYL BENZENE COPOLYMER 
ACACIA 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
CORN SYRUP 
LACTOSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
SOY PROTEIN 
TRIETHYL CITRATE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off-white) Score no score
ShapeROUNDSize16mm
FlavorMINTImprint Code NL4S
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0447-0148 LOZENGE In 1 CONTAINERNone
20135-0447-0272 LOZENGE In 1 CONTAINERNone
30135-0447-03168 LOZENGE In 1 CONTAINERNone
40135-0447-07144 LOZENGE In 1 CONTAINERNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133002/13/2004

Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)
Revised: 01/2010GlaxoSmithKline Consumer Healthcare LP