NICORETTE FRUIT CHILL NICOTINE POLACRILEX- nicotine gum, chewing

Nicorette Fruit Chill nicotine polacrilex by

Drug Labeling and Warnings

Nicorette Fruit Chill nicotine polacrilex by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Use

• 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.

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
• history of seizures

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
• you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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.

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
• begin using the gum on your quit day
• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum
• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum 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. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other information

• each piece contains: calcium 94 mg, sodium 13 mg
• store at 20 - 25°C (68 - 77°F)
• protect from light

Inactive ingredients

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Questions or comments?

call toll-free 1-800-419-4766

SPL UNCLASSIFIED SECTION

Repackaged and Distributed with Permission of the Manufacturer by
Convenience Valet®, Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 10 Piece Blister Pack Carton

This package size may not be
a full day's supply; it is intended
to start or continue a quit attempt.

gsk

NDC: 0135-0242-11

Nicorette®
nicotine polacrilex gum, 4 mg stop smoking aid
Gum

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 Nicorette® 2 mg Gum

Coated
FOR BOLD FLAVOR

Fruit Chill®

10 PIECES, 4 mg EACH

INGREDIENTS AND APPEARANCE

NICORETTE FRUIT CHILL NICOTINE POLACRILEX 
nicotine gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-5270
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R)	Nicotine	4 mg

Inactive Ingredients
Ingredient Name	Strength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	YELLOW	Score	no score
Shape	SQUARE	Size	15mm
Flavor	FRUIT	Imprint Code	N4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-5270-1	1 in 1 CARTON	09/14/2009
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020066	09/14/2009

Labeler - Mechanical Servants LLC (005530951)

Establishment
Name	Address	ID/FEI	Business Operations
Mechanical Servants LLC		005530951	REPACK(29485-5270) , RELABEL(29485-5270)

Establishment
Name	Address	ID/FEI	Business Operations
GlaxoSmithKline		046877908	MANUFACTURE(29485-5270)