Drug Facts

Drug Facts
SPL v27
SPL
SPL Set ID 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c
Route
ORAL
Published
Effective Date 2024-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (2 mg)
Inactive Ingredients
Polacrilin Acesulfame Potassium Carnauba Wax Hypromellose, Unspecified Magnesium Oxide Menthol, Unspecified Form Peppermint Oil Polysorbate 80 Sodium Bicarbonate Sodium Carbonate Sucralose Titanium Dioxide Xylitol D&c Yellow No. 10 Aluminum Oxide Glycerin Sorbitol Acacia

Identifiers & Packaging

Pill Appearance
Imprint: N4 Shape: square Color: white Color: brown Color: yellow Size: 15 mm Size: 14 mm Score: 1
Marketing Status
NDA Active Since 2017-09-13 Until 2019-08-01

Description

Nicotine polacrilex (equal to 2 mg nicotine) Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine polacrilex (equal to 2 mg nicotine) Nicotine polacrilex (equal to 4 mg nicotine)

Use
  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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.
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 provider 
Questions Or Comments?

call toll-free 1-888-569-1743

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

Other Information (mint)
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
Inactive Ingredients (mint)

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

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

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

Other Information (cinnamon Surge)
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
Other Information (white Ice Mint)
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
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
Other Information (spearmint Burst)
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
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 (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 (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

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.

Active Ingredient (in Each Chewing Piece)

Nicotine polacrilex (equal to 2 mg nicotine)

Nicotine polacrilex (equal to 4 mg nicotine)

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.

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.
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.


Structured Label Content

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

Stop smoking aid

Directions (2 Mg) (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.
Directions (4 Mg) (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 provider 
Questions Or Comments? (Questions or comments?)

call toll-free 1-888-569-1743

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

Other Information (mint) (Other information (Mint))
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
Inactive Ingredients (mint) (Inactive ingredients (Mint))

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

Other Information (original) (Other information (Original))
  • each piece contains:calcium 117 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light
Stop Use and Ask A Doctor If (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)
Inactive Ingredients (original) (Inactive ingredients (Original))

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

Other Information (cinnamon Surge) (Other information (Cinnamon Surge))
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
Other Information (white Ice Mint) (Other information (White Ice Mint))
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
Ask A Doctor Before Use If You Have (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
Other Information (spearmint Burst) (Other information (Spearmint Burst))
  • (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 - 25 oC (68 - 77 oF)
  • protect from light
Inactive Ingredients (cinnamon Surge) (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 (white Ice Mint) (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 (spearmint Burst) (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

Keep Out of Reach of Children and Pets. (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.

Active Ingredient (in Each Chewing Piece) (Active ingredient (in each chewing piece))

Nicotine polacrilex (equal to 2 mg nicotine)

Nicotine polacrilex (equal to 4 mg nicotine)

Additional Information Found On Packaging (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.

Ask A Doctor Or A Pharmacist Before Use If You Are (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.
If You Are Pregnant Or Breast Feeding, Only Use This Medicine On the Advice of Your Health Care Provider. (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.


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