Nicotine Gum, Chewing
FDA Label NDC 55154-6818

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Nicotine (NDC 55154-6818). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each chewing piece) - 2 mg, active ingredient (in each chewing piece) - 4 mg, purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Chewing Piece) - 2 Mg

→ Active Ingredient (in Each Chewing Piece) - 4 Mg

→ Purpose

→ Use

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children And Pets.

→ Directions - 2 Mg

→ Directions - 4 Mg

→ Other Information - 2 Mg

→ Other Information - 4 Mg

→ Inactive Ingredients - 2 Mg

→ Inactive Ingredients - 4 Mg

→ Questions Or Comments?

→ Generic Information

→ Principal Display Panel

Active Ingredient (In Each Chewing Piece) - 2 Mg

Nicotine Polacrilex (equal to 2 mg nicotine)

Active Ingredient (In Each Chewing Piece) - 4 Mg

Nicotine Polacrilex (equal to 4 mg 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.

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 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
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 (1-800-222-1222) right away.

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 our health care provider.

Other Information - 2 Mg

each piece contains: calcium 115 mg, sodium 8 mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other Information - 4 Mg

each piece contains: calcium 120 mg, sodium 8 mg
store at 20 - 25°C (68 - 77°F)
protect from light

Inactive Ingredients - 2 Mg

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, xylitol.

Inactive Ingredients - 4 Mg

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, xylitol.

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com

Overbagged with 10 chewing gum per bag, NDC 55154-6818-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L6156095-10826 / L6156095-20826

Product of United Kingdom

PLD-G618C	FC009762	Rev. 02/26	R-58	Re-order No. 370061
PLD-G624C	FC009805	Rev. 02/26	R-58	Re-order No. 370000

Generic Information

* This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum.

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks,

3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.

4. Use With a Support Program as directed in the enclosed User's Guide.

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

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.