Label: NICORETTE WHITE ICE MINT- nicotine polacrilex gum, chewing
NICORETTE ORIGINAL- nicotine polacrilex gum, chewing
NICORETTE CINNAMON SURGE- nicotine polacrilex gum, chewing
NICORETTE MINT- nicotine polacrilex gum, chewing
NICORETTE SPEARMINT BURST- nicotine polacrilex gum, chewing
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NDC Code(s):
0135-0157-07,
0135-0157-10,
0135-0157-11,
0135-0157-12, view more0135-0158-07, 0135-0158-10, 0135-0158-11, 0135-0158-12, 0135-0229-03, 0135-0229-04, 0135-0229-05, 0135-0230-03, 0135-0230-04, 0135-0230-05, 0135-0355-03, 0135-0466-01, 0135-0466-02, 0135-0466-03, 0135-0466-05, 0135-0466-07, 0135-0466-08, 0135-0466-14, 0135-0467-01, 0135-0467-02, 0135-0467-05, 0135-0467-07, 0135-0467-08, 0135-0467-14, 0135-0474-01, 0135-0474-02, 0135-0474-05, 0135-0474-08, 0135-0474-14, 0135-0474-15, 0135-0474-17, 0135-0474-18, 0135-0474-19, 0135-0474-20, 0135-0475-01, 0135-0475-02, 0135-0475-03, 0135-0475-05, 0135-0475-08, 0135-0475-14, 0135-0475-15, 0135-0475-17, 0135-0475-18, 0135-0475-19, 0135-0475-20, 0135-0532-02, 0135-0532-03, 0135-0532-12, 0135-0532-13, 0135-0532-14, 0135-0533-02, 0135-0533-12, 0135-0533-13, 0135-0533-14
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 13, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewing piece)
- Purpose
- Use
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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 a pharmacist before use if you are
- using a non-nicotine stop smoking drug
- taking a 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)
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Directions (2 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
- begin using the gum on your quit day
- if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine gum
- if you smoke your first cigarette more than 30 minutes after waking up,use 2 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.
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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
- 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 providerÂ
- Other information (White Ice Mint)
- Other information (Original)
- Other information (Cinnamon Surge)
- Other information (Mint)
- Other information (Spearmint Burst)
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Inactive ingredients (White Ice Mint)
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
- Inactive ingredients (Original)
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Inactive ingredients (Cinnamon Surge)
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
- Inactive ingredients (Mint)
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Inactive ingredients (Spearmint Burst)
each 2 mg piece contains:acacia, acesulfame potassium, carnauba wax, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, 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, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol
- Questions or comments?
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Additional information found on packaging
Includes Quit Support Program
TO INCREASE YOUR SUCCESS IN QUITTING:
- You must be motivated to quit.
- Use Enough– Chew at least 9 piecesof Nicorette gum per day during the first six weeks.
- Use Long Enough– Use Nicorette gum for the full 12 weeks.
- Use with a support programas 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.
Nicorette is proud to offer a free individualized quit support program! Visit www.quit.com/join-myquit for details.
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Principal Display Panel
NDC 0135-0474-02 HALEON
NICORETTE
nicotine polacrilex gum, 2 mg stop smoking aid
Gum
2 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum
COATED FOR BOLD FLAVOR
100 PIECES,2 mg EACH
White Ice Mint
824747 Front Label
-
Principal Display Panel
NDC 0135-0475-02 HALEON
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 THAN30 MINUTES after waking up, use Nicorette 2 mg Gum.
COATED FOR BOLD FLAVOR
100 PIECES,4 mg EACH
White Ice Mint
824750 Front Label
-
Principal Display Panel
NDC 0135-0157-11 HALEON
NICORETTE
nicotine polacrilex gum, 2 mg stop smoking aid
Gum
2 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum
200 PIECES,2 mg EACH
Original
824754 Front Label
-
Principal Display Panel
NDC 0135-0158-11 HALEON
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 THAN30 MINUTES after waking up, use Nicorette 2 mg Gum.
200 PIECES, 4 mg EACH
Original
824757 Front Label
-
Principal Display Panel
NDC 0135-0466-02 HALEON
NICORETTE
nicotine polacrilex gum, 2 mg stop smoking aid
Gum
2 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum
COATED FOR BOLD FLAVOR
100 PIECES
2 mg EACH
Cinnamon Surge
824735 Front Label
-
Principal Display Panel
NDC 0135-0467-02 HALEON
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 THAN30 MINUTES after waking up, use Nicorette 2 mg Gum.
COATED FOR BOLD FLAVOR
100 PIECES
4 mg EACH
Cinnamon Surge
824738 Front Label
-
Principal Display Panel
NDC 0135-0229-05 HALEON
NICORETTE
nicotine polacrilex gum, 2 mg stop smoking aid
Gum
2 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum
170 PIECES, 2 mg EACH
Mint
824762 Front Label
-
Principal Display Panel
NDC 0135-0230-05 HALEON
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 THAN30 MINUTES after waking up, use Nicorette 2 mg Gum
170 PIECES, 4 mg EACH
Mint
824763 Front Label
-
Principal Display Panel
NDC 0135-0532-02 HALEON
NICORETTE
nicotine polacrilex gum, 2 mg stop smoking aid
Gum
2 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum
COATED FOR BOLD FLAVOR
100 PIECES, 2 mg EACH
Spearmint Burstwith a hint of chamomile
824758 Front Label
-
Principal Display Panel
NDC 0135-0533-02 HALEON
NICORETTE
nicotine polacrilex gum, 2 mg stop smoking aid
Gum
4 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 2 mg Gum
COATED FOR BOLD FLAVOR
100 PIECES, 4 mg EACH
Spearmint Burstwith a hint of chamomile
824760 Front Label
-
Principal Display Panel
NDC 0135-0355-03 HALEON
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 THAN30 MINUTES after waking up, use Nicorette 2 mg Gum
COATED FOR BOLD FLAVOR
160 PIECES, 4 mg EACH
Spearmint Burstwith a hint of chamomile
824761 Front Label
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INGREDIENTS AND APPEARANCE
NICORETTE Â WHITE ICE MINT
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0474 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)  CARNAUBA WAX (UNII: R12CBM0EIZ)  HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  PEPPERMINT OIL (UNII: AV092KU4JH)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SODIUM BICARBONATE (UNII: 8MDF5V39QO)  SODIUM CARBONATE (UNII: 45P3261C7T)  SUCRALOSE (UNII: 96K6UQ3ZD4)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  XYLITOL (UNII: VCQ006KQ1E)  Product Characteristics Color white Score no score Shape SQUARE Size 15mm Flavor MINT (White Ice Mint) Imprint Code N2 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0474-01 1 in 1 CARTON 06/29/2009 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0474-02 1 in 1 CARTON 06/29/2009 2 100 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0474-05 1 in 1 CARTON 06/29/2009 3 160 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0474-08 20 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 5 NDC:0135-0474-14 25 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 08/01/2018 6 NDC:0135-0474-15 8 in 1 PACKAGE 06/29/2009 08/01/2018 6 25 in 1 CARTON; Type 0: Not a Combination Product 7 NDC:0135-0474-17 1 in 1 CARTON 06/29/2009 7 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 8 NDC:0135-0474-18 2 in 1 PACKAGE 08/01/2014 8 10 in 1 CARTON 8 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:0135-0474-19 12 in 1 CARTON 09/01/2018 9 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 10 NDC:0135-0474-20 18 in 1 CARTON 12/03/2018 10 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 06/29/2009 NICORETTE  WHITE ICE MINT
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0475 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)  Product Characteristics Color white (cream) Score no score Shape SQUARE Size 15mm Flavor MINT (White Ice Mint) Imprint Code N4 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0475-01 1 in 1 CARTON 06/29/2009 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0475-02 1 in 1 CARTON 06/29/2009 2 100 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0475-03 1 in 1 CARTON 06/29/2009 08/01/2019 3 190 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0475-05 1 in 1 CARTON 06/29/2009 4 160 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:0135-0475-08 20 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 6 NDC:0135-0475-14 25 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 08/01/2018 7 NDC:0135-0475-15 8 in 1 PACKAGE 06/29/2009 08/01/2018 7 25 in 1 CARTON; Type 0: Not a Combination Product 8 NDC:0135-0475-17 1 in 1 CARTON 06/29/2009 8 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:0135-0475-18 2 in 1 PACKAGE 08/01/2014 9 10 in 1 CARTON 9 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 10 NDC:0135-0475-19 12 in 1 CARTON 09/01/2018 10 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 11 NDC:0135-0475-20 18 in 1 CARTON 12/03/2018 11 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 06/29/2009 NICORETTE  ORIGINAL
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0157 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 (beige) Score no score Shape SQUARE Size 14mm Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0157-07 1 in 1 CARTON 06/29/2009 1 110 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0157-10 1 in 1 CARTON 06/29/2009 2 170 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0157-11 1 in 1 CARTON 06/29/2009 3 200 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0157-12 1 in 1 CARTON 06/29/2009 08/01/2019 4 220 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 06/29/2009 NICORETTE  ORIGINAL
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0158 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 (beige) Score no score Shape SQUARE Size 14mm Flavor Imprint Code Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0158-07 1 in 1 CARTON 06/29/2009 1 110 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0158-10 1 in 1 CARTON 06/29/2009 2 170 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0158-11 1 in 1 CARTON 06/29/2009 3 200 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0158-12 1 in 1 CARTON 06/29/2009 08/01/2019 4 220 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 06/29/2009 NICORETTE  CINNAMON SURGE
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0466 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)  ACACIA (UNII: 5C5403N26O)  ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  CARNAUBA WAX (UNII: R12CBM0EIZ)  HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  PEPPERMINT OIL (UNII: AV092KU4JH)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SODIUM BICARBONATE (UNII: 8MDF5V39QO)  SODIUM CARBONATE (UNII: 45P3261C7T)  SUCRALOSE (UNII: 96K6UQ3ZD4)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  XYLITOL (UNII: VCQ006KQ1E)  Product Characteristics Color white Score no score Shape SQUARE Size 15mm Flavor CINNAMON Imprint Code N2 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0466-01 1 in 1 CARTON 06/29/2009 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0466-02 1 in 1 CARTON 06/29/2009 2 100 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0466-03 1 in 1 CARTON 06/29/2009 3 190 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0466-05 1 in 1 CARTON 06/29/2009 4 160 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:0135-0466-07 1 in 1 CARTON 06/29/2009 5 40 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:0135-0466-08 20 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 7 NDC:0135-0466-14 25 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018612 06/29/2009 NICORETTE  CINNAMON SURGE
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0467 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)  ACACIA (UNII: 5C5403N26O)  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)  Product Characteristics Color white (cream) Score no score Shape SQUARE Size 15mm Flavor CINNAMON Imprint Code N4 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0467-01 1 in 1 CARTON 06/29/2009 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0467-02 1 in 1 CARTON 06/29/2009 2 100 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0467-05 1 in 1 CARTON 06/29/2009 3 160 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0467-07 1 in 1 CARTON 06/29/2009 4 40 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:0135-0467-08 20 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 6 NDC:0135-0467-14 25 in 1 CARTON; Type 0: Not a Combination Product 06/29/2009 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020066 06/29/2009 NICORETTE  MINT
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0229 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 brown (beige) 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:0135-0229-03 1 in 1 CARTON 06/29/2009 08/01/2019 1 50 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0229-04 1 in 1 CARTON 06/29/2009 08/01/2019 2 110 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0229-05 1 in 1 CARTON 06/29/2009 3 170 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 06/29/2009 NICORETTE  MINT
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0230 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 brown (beige) 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:0135-0230-03 1 in 1 CARTON 06/29/2009 1 50 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0230-04 1 in 1 CARTON 06/29/2009 08/01/2019 2 110 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0230-05 1 in 1 CARTON 06/29/2009 3 170 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 06/29/2009 NICORETTE  SPEARMINT BURST
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0532 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)  ACACIA (UNII: 5C5403N26O)  ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  CARNAUBA WAX (UNII: R12CBM0EIZ)  HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  PEPPERMINT OIL (UNII: AV092KU4JH)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  SODIUM BICARBONATE (UNII: 8MDF5V39QO)  SODIUM CARBONATE (UNII: 45P3261C7T)  SUCRALOSE (UNII: 96K6UQ3ZD4)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  XYLITOL (UNII: VCQ006KQ1E)  Product Characteristics Color white (beige) Score no score Shape SQUARE Size 15mm Flavor SPEARMINT Imprint Code N2 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0532-02 10 in 1 CARTON 09/13/2017 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0532-03 16 in 1 CARTON 09/13/2017 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0532-12 2 in 1 PACKAGE 03/01/2018 3 10 in 1 CARTON 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0532-13 12 in 1 CARTON 09/01/2018 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:0135-0532-14 18 in 1 CARTON 12/03/2018 5 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 09/13/2017 NICORETTE  SPEARMINT BURST
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0533 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)  ACACIA (UNII: 5C5403N26O)  ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  CARNAUBA WAX (UNII: R12CBM0EIZ)  D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  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)  Product Characteristics Color yellow Score no score Shape SQUARE Size 15mm Flavor SPEARMINT Imprint Code N4 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0533-02 10 in 1 CARTON 09/13/2017 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0135-0533-12 2 in 1 PACKAGE 03/01/2018 2 10 in 1 CARTON 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0135-0533-13 12 in 1 CARTON 09/01/2018 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0135-0533-14 18 in 1 CARTON 12/03/2018 4 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 09/13/2017 NICORETTE  SPEARMINT BURST
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0355 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)  ACACIA (UNII: 5C5403N26O)  ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  CARNAUBA WAX (UNII: R12CBM0EIZ)  D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  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)  Product Characteristics Color yellow Score no score Shape SQUARE Size 15mm Flavor SPEARMINT Imprint Code N4 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0355-03 16 in 1 CARTON 09/13/2017 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 09/13/2017 Labeler - Haleon US Holdings LLC (079944263)