LEADER NICOTINE - nicotine lozenge 
Cardinal Health

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Cardinal Health Nicotine Polacrilex Lozenge 2 mg (nicotine) Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 2 mg (nicotine)

Purpose

Stop smoking aid

Uses

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

Weeks 1 to 6Weeks 7 to 9Weeks 10 to 12

1 lozenge every

1 to 2 hours

1 lozenge every

2 to 4 hours

1 lozenge every

4 to 8 hours

Other information

Inactive ingredients

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

Questions or comments?

call toll-free 1-866-751-9303

Principal Display Panel

Compare to Commit® Lozenge active ingredient

Nicotine Polacrilex Lozenge 2 mg (nicotine)

Stop Smoking Aid

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 Nicotine Polacrilex Lozenge, 4 mg

Mint Flavor

2 mg

Includes User's Guide

QuitTube

(# QuitTube™ containers of #) {Replace the first "#" with the actual # of Containers and the second "#" with the # of Lozenges in each container}

Nicotine Polacrilex Lozenge 2 mg (nicotine) Carton Image 1

Nicotine Polacrilex Lozenge 2 mg (nicotine) Carton Image 1

Nicotine Polacrilex Lozenge 2 mg (nicotine) Carton Image 2

Nicotine Polacrilex Lozenge 2 mg (nicotine) Carton Image 2


LEADER NICOTINE 
nicotine polacrilex   lozenge
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)37205-987
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
MAGNESIUM STEARATE 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
XANTHAN GUM 
POLACRILIN 
Product Characteristics
ColorWHITEScore no score
ShapeROUNDSize16mm
FlavorMINTImprint Code L344
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
137205-987-693 VIAL In 1 CARTONcontains a VIAL
124 LOZENGE In 1 VIALThis package is contained within the CARTON (37205-987-69)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07700710/08/2009

Labeler - Cardinal Health (097537435)
Revised: 10/2009Cardinal Health