Active ingredient (in each lozenge)

Nicotine polacrilex, 2 mg (nicotine)

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 products

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 or 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

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 4 mg nicotine lozenge
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg 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 feel 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 15 mg
Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge
sugar alcohol content: 1 g mannitol per lozenge
store at 20-25°C (68-77°F)
keep vial closed and protect from light

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 the active ingredient of Commit® Lozenge

Nicotine Polacrilex Lozenge 2 mg (nicotine)

Stop Smoking Aid

Quit Tube

Mint

2 mg

Actual Size

Includes Users' Guide

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

Sugar Free

2 mg each

(# QuitTube™ containers of #)

Nicotine Polacrilex Lozenge 2 mg (Nicotine) Carton

IN CONTROL NICOTINE
nicotine polacrilex lozenge

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	37808-344
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
No Inactive Ingredients Found

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	16mm
Flavor	MINT	Imprint Code	L344
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	37808-344-03	1 VIAL In 1 CARTON	contains a VIAL
1		24 LOZENGE In 1 VIAL	This package is contained within the CARTON (37808-344-03)
2	37808-344-05	3 VIAL In 1 CARTON	contains a VIAL
2		24 LOZENGE In 1 VIAL	This package is contained within the CARTON (37808-344-05)
3	37808-344-06	4 VIAL In 1 CARTON	contains a VIAL
3		24 LOZENGE In 1 VIAL	This package is contained within the CARTON (37808-344-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077007	07/25/2007

Labeler - H E B (007924756)

Revised: 06/2009H E B