Nicorette ®

Nicorette ®
SPL v6
SPL
SPL Set ID 01db011d-924c-40e4-bd5d-44eb267b8de1
Route
ORAL
Published
Effective Date 2019-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (4 mg)
Inactive Ingredients
Polacrilin Acesulfame Potassium Carnauba Wax D&c Yellow No. 10 Aluminum Oxide Hypromellose, Unspecified Magnesium Oxide Menthol, Unspecified Form Peppermint Oil Polysorbate 80 Sodium Carbonate Sucralose Titanium Dioxide Xylitol Acacia

Identifiers & Packaging

Pill Appearance
Imprint: N4 Shape: square Color: yellow Size: 15 mm Score: 1
Marketing Status
NDA Active Since 2009-09-14

Description

Drug Facts

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Drug Facts

Use
  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 53414-9

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.

Directions
  • 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.
Other Information
  • each piece contains: calcium 94 mg, sodium 13 mg
  • store at 20 - 25°C (68 - 77°F)
  • protect from light
Inactive Ingredients

acacia, 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, sucralose, titanium dioxide, xylitol

Questions Or Comments?

call toll-free 1-800-419-4766

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
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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
Active Ingredient (in Each Chewing Piece)

Nicotine polacrilex (equal to 4 mg nicotine)

Ask A Doctor Or 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.
Principal Display Panel 10 Piece Blister Pack Carton

This package size may not be

a full day's supply; it is intended

to start or continue a quit attempt.

gsk

NDC 0135-0242-11

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 THAN

30 MINUTES after waking

up, use Nicorette ® 2 mg Gum

Coated

FOR BOLD FLAVOR

Fruit Chill ®

10 PIECES, 4 mg EACH


Structured Label Content

Use
  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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.

Purpose

Stop smoking aid

Directions
  • 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.
Other Information (Other information)
  • each piece contains: calcium 94 mg, sodium 13 mg
  • store at 20 - 25°C (68 - 77°F)
  • protect from light
Inactive Ingredients (Inactive ingredients)

acacia, 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, sucralose, titanium dioxide, xylitol

Questions Or Comments? (Questions or comments?)

call toll-free 1-800-419-4766

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
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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
Active Ingredient (in Each Chewing Piece) (Active ingredient (in each chewing piece))

Nicotine polacrilex (equal to 4 mg nicotine)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or 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.
Principal Display Panel 10 Piece Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 Piece Blister Pack Carton)

This package size may not be

a full day's supply; it is intended

to start or continue a quit attempt.

gsk

NDC 0135-0242-11

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 THAN

30 MINUTES after waking

up, use Nicorette ® 2 mg Gum

Coated

FOR BOLD FLAVOR

Fruit Chill ®

10 PIECES, 4 mg EACH


Advanced Ingredient Data


Raw Label Data

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