Nicotine Polacrilex

Drug Facts

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

• 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 4 mg

• 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.

Other information (mint flavor)

• each 2 mg piece contains: calcium 94 mg, sodium 13 mg


• each 4 mg piece contains: calcium 94 mg, sodium 14 mg


• store at 20 - 25oC (68 - 77oF)


• protect from light

Other information (original flavor)

• each 2 mg piece contains: calcium 117 mg, sodium 13 mg


• each 4 mg piece contains: calcium 117 mg, sodium 14 mg


• store at 20 - 25oC (68 - 77oF)


• protect from light

Distributed by Target Corporation

Minneapolis, MN 55403

Made in Sweden

©2010 Target Brands, Inc.

All RIGHTS Reserved Shop Target.com

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

• 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.

  
  

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 Al. lake, 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)

Send comments/questions to:

Consumer Relations

Dept. TG

P.O. Box 517

Parsippany, NJ 07054-9904

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 

ACTUAL SIZE

170 PIECES, 2mg EACH

mint flavor

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 

ACTUAL SIZE

170 PIECES, 4mg EACH

mint flavor

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 LESS THAN 25 CIGARETTES A DAY

If you smoke 25 or more cigarettes a day: use nicotine gum, 4mg

up&upTM 

ACTUAL SIZE

110 PIECES, 2mg EACH

original flavor

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 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day: use nicotine gum, 2mg

up&upTM 

ACTUAL SIZE

110 PIECES, 4mg EACH

original flavor

Nicotine Polacrilex  Nicotine Polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-229 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 POLACRILIN   ACESULFAME POTASSIUM   MAGNESIUM OXIDE   MENTHOL   PEPPERMINT OIL   SODIUM BICARBONATE   SODIUM CARBONATE   XYLITOL

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

Packaging # NDC Package Description Multilevel Packaging 1 11673-229-05 170 PIECE In 1 BLISTER PACK None 2 11673-229-04 110 PIECE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018612	02/15/2010

Nicotine Polacrilex  Nicotine Polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-230 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength POLACRILIN   ACESULFAME POTASSIUM   D&C YELLOW NO. 10   ALUMINUM OXIDE   MAGNESIUM OXIDE   MENTHOL   PEPPERMINT OIL   SODIUM CARBONATE   XYLITOL

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

Packaging # NDC Package Description Multilevel Packaging 1 11673-230-04 110 PIECE In 1 BLISTER PACK None 2 11673-230-05 170 PIECE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020066	02/15/2010

Nicotine Polacrilex  Nicotine Polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-658 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength POLACRILIN   D&C YELLOW NO. 10   GLYCERIN   SODIUM CARBONATE   SORBITOL

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

Packaging # NDC Package Description Multilevel Packaging 1 11673-658-02 110 PIECE In 1 BLISTER PACK None 2 11673-658-03 170 PIECE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020066	02/15/2010

Nicotine Polacrilex  Nicotine Polacrilex  gum, chewing

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-657 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 POLACRILIN   GLYCERIN   SODIUM BICARBONATE   SODIUM CARBONATE   SORBITOL

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

Packaging # NDC Package Description Multilevel Packaging 1 11673-657-03 170 PIECE In 1 BLISTER PACK None 2 11673-657-02 110 PIECE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018612	02/15/2010

Labeler - Target Corporation (006961700)

Revised: 05/2010Target Corporation

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