Nicorette description, usages, side effects, indications, overdosage, supplying and lots more!

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Nicorette

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Nicotine polacrilex (equal to 2mg nicotine)

Nicotine polacrilex (equal to 4mg nicotine)

Stop smoking aid

  • •reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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

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
  • (For Cinnamon Surge) oral blistering occurs
  • •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.

  • 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 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. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
  • 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 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. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider 
  • (2 mg) each piece contains: calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains: calcium 94 mg, sodium 13 mg
  • •store at 20 - 25oC (68 - 77oF)
  • •protect from light
  • each piece contains: calcium 117 mg, sodium 13 mg
  • •store at 20 - 25oC (68 - 77oF)
  • •protect from light
  • (2 mg) each piece contains: calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains: calcium 94 mg, sodium 13 mg
  • •store at 20 - 25oC (68 - 77oF)
  • •protect from light
  • (2 mg) each piece contains: calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains: calcium 94 mg, sodium 13 mg
  • •store at 20 - 25oC (68 - 77oF)
  • •protect from light
  • (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
  • (2 mg) each piece contains: calcium 94mg, sodium 11mg
  • (4 mg) each piece contains: calcium 94mg, sodium 13mg
  • •store at 20 - 25oC (68 - 77oF)
  • •protect from light

each 2 mg piece contains: acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: 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, starch, sucralose, titanium dioxide, xylitol

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

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol

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

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

each 2 mg piece contains: acesulfame potassium, carnauba wax, chamomile flavor, edible ink, gum base, gum arabica, hypromellose, levomenthol, magnesium oxide, peppermint flavor, polysorbate 80, spearmint flavor, sodium carbonate, sodium hydrogen carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains: acesulfame potassium, carnauba wax, chamomile flavor, D&C yllow #10 Al. lake, edible ink, gum base, gum arabica, hypromellose, levomenthol, magnesium oxide, peppermint flavor, polysorbate 80, spearmint flavor, sodium carbonate, sucralose, titanium dioxide, xylitol

call toll-free 1-800-419-4766 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)

TO INCREASE YOUR SUCCESS IN QUITTING:

  • 1.You must be motivated to quit.
  • 2. Use Enough – Chew at least 9 pieces of Nicorette gum per day during the first six weeks.
  • 3. Use Long Enough – Use Nicorette gum for the full 12 weeks.
  • 4. 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.

  • •not for sale to those under 18 years of age
  • •proof of age 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.

Distributed by

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Sweden

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.

Free Audio CD upon request. See inside.

Principal Display Panel

NDC 0135-0474-02

Nicorette®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

White Ice Mint®

2 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 Nicorette 4mg Gum

100 PIECES, 2mg EACH

NICORETTE ,WHITE ICE MINT and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

30462XD

Principal Display Panel

NDC 0135-0475-02

Nicorette®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

White Ice Mint®

4 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 2mg Gum

100 PIECES, 4mg EACH

NICORETTE ,WHITE ICE MINT and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

30463XD

Principal Display Panel

NDC 0135-0157-07

Nicorette®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Original 

2 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 Nicorette 4mg Gum

110 PIECES, 2mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

29545XE

Principal Display Panel

NDC 0135-0158-07

Nicorette®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Original

4 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 2mg Gum

110 PIECES, 4mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

29546XE

Principal Display Panel

NDC 0135-0466-02

Nicorette®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon Surge®

2 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 Nicorette 4mg Gum

100 PIECES, 2mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks and CINNAMON SURGE is a trademark of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

30214XD

Principal Display Panel

 NDC 0135-0467-02

Nicorette®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon Surge®

4 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 2mg Gum

100 PIECES, 4mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks and CINNAMON SURGE is a trademark of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

30215XD

Principal Display Panel

 NDC 0135-0225-02

Nicorette®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh MintTM

2 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 Nicorette 4mg Gum

100 PIECES, 2mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks and FRESH MINT is a trademark of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

29547XF

Principal Display Panel

NDC 0135-0226-02

Nicorette®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh MintTM

4 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 2mg Gum

100 PIECES, 4mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks and FRESH MINT is a trademark of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

29548XF

Principal Display Panel

NDC 0135-0229-04

Nicorette®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Mint

2 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 Nicorette 4mg Gum

110 PIECES, 2mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

29552XE

Principal Display Panel

NDC 0135-0230-04

Nicorette®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Mint 

4 mg

NEW DIRECTIONS FOR USE

        • - Keep Using if You Slip Up and Have a Cigarette
        • - Use Beyond 12 Weeks if Needed to Quit

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 2mg Gum

110 PIECES, 4mg EACH

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

29553XE

Principal Display Panel

NDC 0135-0532-02

Nicorette®

nicotine polacrilex gum, 2mg

stop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint BurstTM with a hint of chamomile

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 Nicorette 4mg Gum

100 PIECES, 2mg EACH

NICORETTE is a registered trademark and the NICORETTE burst design and SPEARMINT BURST are trademarks of the GlaxoSmithKline group of companies.

©2012 GlaxoSmithKline

101782XA

Principal Display Panel

NDC 0135-0533-02

Nicorette®

nicotine polacrilex gum, 4mg

stop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint BurstTM with a hint of chamomile

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 2mg Gum

100 PIECES, 4mg EACH

NICORETTE is a registered trademark and the NICORETTE burst design and SPEARMINT BURST are trademarks of the GlaxoSmithKline group of companies.

©2012 GlaxoSmithKline

101781XA

Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0474
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
carnauba wax
HYPROMELLOSES
magnesium oxide
MENTHOL
PEPPERMINT OIL
polysorbate 80
SODIUM BICARBONATE
SODIUM CARBONATE
Sucralose
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE 15 mm N2 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 40 in 1 BLISTER PACK
3 100 in 1 BLISTER PACK
4 160 in 1 BLISTER PACK
5 190 in 1 BLISTER PACK
6 210 in 1 BLISTER PACK
7 120 in 1 BLISTER PACK
8 NDC:0135-0474-08 20 in 1 CARTON
9 NDC:0135-0474-14 25 in 1 CARTON
10 25 in 1 CARTON
11 NDC:0135-0474-15 8 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0475
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
carnauba wax
D&C YELLOW NO. 10
ALUMINUM OXIDE
HYPROMELLOSES
magnesium oxide
MENTHOL
PEPPERMINT OIL
polysorbate 80
SODIUM CARBONATE
Sucralose
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE (cream) 15 mm N4 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 40 in 1 BLISTER PACK
3 100 in 1 BLISTER PACK
4 160 in 1 BLISTER PACK
5 190 in 1 BLISTER PACK
6 210 in 1 BLISTER PACK
7 120 in 1 BLISTER PACK
8 NDC:0135-0475-08 20 in 1 CARTON
9 NDC:0135-0475-14 25 in 1 CARTON
10 25 in 1 CARTON
11 NDC:0135-0475-15 8 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0157
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
GLYCERIN
SODIUM BICARBONATE
SODIUM CARBONATE
sorbitol

Product Characteristics

Color Size Shape
WHITE (beige) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BLISTER PACK
2 110 in 1 BLISTER PACK
3 170 in 1 BLISTER PACK
4 200 in 1 BLISTER PACK
5 220 in 1 BLISTER PACK
6 NDC:0135-0157-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0158
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
D&C YELLOW NO. 10
GLYCERIN
SODIUM CARBONATE
sorbitol

Product Characteristics

Color Size Shape
WHITE (beige) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BLISTER PACK
2 110 in 1 BLISTER PACK
3 170 in 1 BLISTER PACK
4 200 in 1 BLISTER PACK
5 220 in 1 BLISTER PACK
6 NDC:0135-0158-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0466
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
HYPROMELLOSES
magnesium oxide
MENTHOL
PEPPERMINT OIL
polysorbate 80
SODIUM BICARBONATE
SODIUM CARBONATE
Sucralose
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE 15 mm N2 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 40 in 1 BLISTER PACK
3 100 in 1 BLISTER PACK
4 160 in 1 BLISTER PACK
5 190 in 1 BLISTER PACK
6 120 in 1 BLISTER PACK
7 210 in 1 BLISTER PACK
8 NDC:0135-0466-08 20 in 1 CARTON
9 NDC:0135-0466-14 25 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0467
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
D&C YELLOW NO. 10
ALUMINUM OXIDE
HYPROMELLOSES
magnesium oxide
MENTHOL
PEPPERMINT OIL
polysorbate 80
SODIUM CARBONATE
Sucralose
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE (cream) 15 mm N4 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 100 in 1 BLISTER PACK
3 190 in 1 BLISTER PACK
4 120 in 1 BLISTER PACK
5 160 in 1 BLISTER PACK
6 210 in 1 BLISTER PACK
7 40 in 1 BLISTER PACK
8 NDC:0135-0467-08 20 in 1 CARTON
9 NDC:0135-0467-14 25 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0225
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
magnesium oxide
MENTHOL
PEPPERMINT OIL
SODIUM BICARBONATE
SODIUM CARBONATE
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE 15 mm N2 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 40 in 1 BLISTER PACK
2 100 in 1 BLISTER PACK
3 160 in 1 BLISTER PACK
4 190 in 1 BLISTER PACK
5 210 in 1 BLISTER PACK
6 NDC:0135-0225-08 20 in 1 CARTON
7 NDC:0135-0225-14 25 in 1 CARTON
8 25 in 1 CARTON
9 NDC:0135-0225-15 8 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0226
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
D&C YELLOW NO. 10
ALUMINUM OXIDE
magnesium oxide
MENTHOL
PEPPERMINT OIL
SODIUM CARBONATE
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE (light cream) 15 mm N4 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BLISTER PACK
2 190 in 1 BLISTER PACK
3 160 in 1 BLISTER PACK
4 210 in 1 BLISTER PACK
5 40 in 1 BLISTER PACK
6 NDC:0135-0226-08 20 in 1 CARTON
7 NDC:0135-0226-14 25 in 1 CARTON
8 25 in 1 CARTON
9 NDC:0135-0226-15 8 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0229
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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 Size Shape
BROWN (beige) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BLISTER PACK
2 110 in 1 BLISTER PACK
3 170 in 1 BLISTER PACK
4 200 in 1 BLISTER PACK
5 NDC:0135-0229-06 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0230
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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 Size Shape
BROWN (beige) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BLISTER PACK
2 110 in 1 BLISTER PACK
3 170 in 1 BLISTER PACK
4 200 in 1 BLISTER PACK
5 NDC:0135-0230-06 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2009-06-29


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0532
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
carnauba wax
CHAMOMILE
ACACIA
HYPROMELLOSES
LEVOMENTHOL
magnesium oxide
PEPPERMINT
polysorbate 80
SPEARMINT
SODIUM CARBONATE
SODIUM BICARBONATE
Sucralose
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE (beige) 14 mm N2 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 10 in 1 BLISTER PACK
5 10 in 1 BLISTER PACK
6 NDC:0135-0532-08 20 in 1 CARTON
7 NDC:0135-0532-09 25 in 1 CARTON
8 20 in 1 CARTON
9 20 in 1 CARTON
10 NDC:0135-0532-11 10 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2011-11-15


Nicorette

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0533
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
carnauba wax
CHAMOMILE
D&C YELLOW NO. 10
ACACIA
HYPROMELLOSES
LEVOMENTHOL
magnesium oxide
PEPPERMINT
polysorbate 80
SPEARMINT
SODIUM CARBONATE
Sucralose
titanium dioxide
Xylitol
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
YELLOW 14 mm N4 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 10 in 1 BLISTER PACK
5 10 in 1 BLISTER PACK
6 NDC:0135-0533-08 20 in 1 CARTON
7 NDC:0135-0533-09 25 in 1 CARTON
8 20 in 1 CARTON
9 20 in 1 CARTON
10 NDC:0135-0533-11 10 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2011-11-15


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