Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 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 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, teeth or jaw problems occur
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.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 gum
if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg
if you smoke your first cigarette within 30 of minutes waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule:

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

nicotine gum is a medicine and must be used a certain way to get the best results
chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
repeat this process until most of the tingle is gone (about 30 minutes)
do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
do not use more than 24 pieces a day
it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.

Other information

each piece contains: calcium 100 mg and sodium 11 mg
store at 20-25°C (68-77°F)
protect from light

Inactive ingredients

acacia, acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, flavors, gum base, maltitol, polysorbate 60, sodium bicarbonate, sodium carbonate, sorbitol, sucralose, talc, titanium dioxide

Questions or comments?

call 1-866-677-7858

Principal Display Panel

Nicotine Polacrilex Gum, USP, 4 mg (nicotine)

Stop Smoking Aid

4 mg

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 Nicotine Polacrilex Gum, 2 mg

Cinnamon Flavor

Actual Size

4 mg Coated Gum

4 mg each

Nicotine Polacrilex Gum, USP, 4 mg (nicotine) Carton

NICOTINE STOP SMOKING AID
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-0442
Route of Administration	ORAL	DEA Schedule

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

Product Characteristics
Color	YELLOW (light yellow)	Score	no score
Shape	RECTANGLE	Size	16mm
Flavor	CINNAMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0113-0442-78	10 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		10 GUM, CHEWING ( PARTS) in 1 BLISTER PACK	This package is contained within the CARTON (0113-0442-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091354	10/31/2011

Labeler - L Perrigo Company (006013346)

Revised: 02/2010 L Perrigo Company