NICOTINE POLACRILEX gum, chewing

NICOTINE POLACRILEX by

Drug Labeling and Warnings

NICOTINE POLACRILEX by is a Otc medication manufactured, distributed, or labeled by Target Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient 2 mg ( in each chewing piece)

Nicotine polacrilex (equal to 2mg nicotine)

Active ingredient 4 mg (in each chewing piece)

Nicotine polacrilex (equal to 4mg 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.

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 a 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.

Directions (2mg mint)

• 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 25 or more cigarettes a day; use 4mg nicotine gum
• if you smoke less than 25 cigarettes a day; use 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.

Directions (4mg mint)

• 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 less than 25 cigarettes a day: use 2mg nicotine gum
• if you smoke 25 or more cigarettes a day; use 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.

Directions (2mg original)

• 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 within 30 minutes of waking up, use 4mg nicotine gum
• if you smoke your first cigarette more than 30 minutes after waking up, use 2mg 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. 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.

Directions (4 mg original)

• 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 2mg nicotine gum
• if you smoke your first cigarette within 30 minutes of waking up, use 4mg 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. 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 (mint flavor)

• (2 mg) each piece contains: calcium 94 mg, sodium 13 mg
• (4 mg) each piece contains: calcium 94 mg, sodium 14 mg
• store at 20 - 25oC (68 - 77oF)
• protect from light

Other information (original flavor)

• each piece contains: calcium 117 mg, sodium 13 mg
• store at 20 - 25oC (68 - 77oF)
• protect from light

Inactive ingredients (mint flavor)

each 2 mg piece contains: acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

each 4 mg piece contains: acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Inactive ingredients (original flavor)

each 2 mg piece contains: flavors, glycerin, gum base, , sodium bicarbonate, sodium carbonate, sorbitol

each 4 mg piece contains: D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Questions and comments?

call toll-free 1-888-367-7919 (English/Spanish) weekdays (10:00 am - 4:30 pm EST)

Free audio CD upon request. See inside.

TO INCREASE YOUR SUCCESS IN QUITTING:

• You must be motivated to quit.
• Use Enough – Chew at least 9 pieces of nicotine polacrilex gum per day during the first six weeks.
• Use Long Enough – Use nicotine polacrilex gum for the full 12 weeks.
• Use with a support program as directed in the enclosed User’s Guide.

To remove the gum, tear off single unit.

Peel off backing starting at corner with loose edge.

Push gum through foil.

Distributed by Target Corporation

Minneapolis, MN 55403

Made in Sweden

All Rights Reserved Shop Target.com

Send comments/questions to:

Consumer Relations

Dept. TG

P.O. Box 517

Parsippany, NJ 07054-9904

• Not for sale to those under 18 years of age.
• Proof of age is required.
• Not for sale in vending machines or from any source where proof of age cannot be verified.

This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open or torn.

Principal Display Panel

NDC: 11673-229-05

nicotine polacrilex gum

2mg (nicotine)

stop smoking aid

Compare to active ingredient in Nicorette®*  Mint Gum

FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY

If you smoke 25 or more cigarettes a day:

use nicotine gum, 4mg

up&upTM 

170 PIECES, 2mg EACH

ACTUAL SIZE

mint flavor

094 09 0250 ID110400

©2010 Target Brands, Inc.

*NICORETTE is a registered trademark of GlaxoSmithKline Consumer Healthcare, L.P.

30726XC

Principal Display Panel

NDC: 11673-230-05

nicotine polacrilex gum

4mg (nicotine)

stop smoking aid

Compare to active ingredient in Nicorette®*  Mint Gum

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day:

use nicotine gum, 2mg

up&upTM 

170 PIECES, 4mg EACH

ACTUAL SIZE

mint flavor

094 09 0249 ID110400

©2010 Target Brands, Inc.

*NICORETTE is a registered trademark of GlaxoSmithKline Consumer Healthcare, L.P.

30874XB

Principal Display Panel

NDC: 11673-657-02

nicotine polacrilex gum

2mg (nicotine)

stop smoking aid

Compare to active ingredient in Nicorette®* Gum

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 gum, 4mg

up&upTM 

110 PIECES, 2mg EACH

ACTUAL SIZE

original flavor

094 09 0483 ID110400

©2011 Target Brands, Inc.

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

29578XF

Principal Display Panel

NDC: 11673-658-02

nicotine polacrilex gum

4mg (nicotine)

stop smoking aid

Compare to active ingredient in Nicorette®* Gum

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 gum, 2mg

up&upTM 

110 PIECES, 4mg EACH

ACTUAL SIZE

original flavor

094 09 0484 ID 110400

©2011 Target Brands, Inc.

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

29579XF

INGREDIENTS AND APPEARANCE

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-229
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Inactive Ingredients
Ingredient Name	Strength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE	Score	no score
Shape	SQUARE	Size	14mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-229-04	11 in 1 CARTON	02/15/2010	08/01/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11673-229-05	17 in 1 CARTON	02/15/2010	08/01/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 11673-229-06	22 in 1 CARTON	02/15/2010	01/05/2021
3		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	NDA018612	02/15/2010	01/05/2021

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-230
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM CARBONATE (UNII: 45P3261C7T)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	YELLOW	Score	no score
Shape	SQUARE	Size	14mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-230-04	11 in 1 CARTON	02/15/2010	08/01/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11673-230-05	17 in 1 CARTON	02/15/2010	08/01/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 11673-230-06	22 in 1 CARTON	02/15/2010	08/01/2018
3		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	02/15/2010	08/01/2018

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-658
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE (cream)	Score	no score
Shape	SQUARE	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-658-02	11 in 1 CARTON	02/15/2010	12/24/2016
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11673-658-03	17 in 1 CARTON	02/15/2010	08/01/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 11673-658-04	22 in 1 CARTON	02/15/2010	03/24/2017
3		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	02/15/2010	08/01/2018

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-657
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Inactive Ingredients
Ingredient Name	Strength
POLACRILIN (UNII: RCZ785HI7S)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE (cream)	Score	no score
Shape	SQUARE	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-657-02	11 in 1 CARTON	02/15/2010	12/31/2016
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11673-657-03	17 in 1 CARTON	02/15/2010	08/01/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 11673-657-04	22 in 1 CARTON	02/15/2010	12/24/2016
3		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	NDA018612	02/15/2010	08/01/2018

Labeler - Target Corporation (006961700)