Nicorette Lozenge
FDA Label NDC 0135-0626

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Nicorette (NDC 0135-0626). 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 lozenge) (2 mg), active ingredient (in each lozenge) (4 mg), purpose, use, if you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider., 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 Lozenge) (2 Mg)

→ Active Ingredient (in Each Lozenge) (4 Mg)

→ Purpose

→ Use

→ If You Are Pregnant Or Breast-feeding, Only Use This Medicine On The Advice Of Your Health Care Provider.

→ 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 (ice Mint)

→ Inactive Ingredients (ice Mint)

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Lozenge) (2 Mg)

Nicotine polacrilex, 2 mg

Active Ingredient (In Each Lozenge) (4 Mg)

Nicotine polacrilex, 4 mg

Purpose

Stop smoking aid

Use

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

heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
high blood pressure not controlled with medication. Nicotine can increase your 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 problems occur
persistent indigestion or severe sore throat occurs
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.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (2 Mg)

if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
before using this product, read the enclosed User’s Guide for complete directions and other important information
begin using the lozenge on your quit day
if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

nicotine lozenge is a medicine and must be used a certain way to get the best results
place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
you may feel a warm or tingling sensation
occasionally move the lozenge from one side of your mouth to the other until completely dissolved
do not eat or drink 15 minutes before using or while the lozenge is in your mouth
to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
it is important to complete treatment. If you feel you need to use the lozenge 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. No studies have been done to show if this product will work for you.
before using this product, read the enclosed User’s Guide for complete directions and other important information
begin using the lozenge on your quit day
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge
if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

nicotine lozenge is a medicine and must be used a certain way to get the best results
place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
you may feel a warm or tingling sensation
occasionally move the lozenge from one side of your mouth to the other until completely dissolved
do not eat or drink 15 minutes before using or while the lozenge is in your mouth
to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Other Information (Ice Mint)

store at 20 - 25°C (68 - 77°F)
Store in the original container

Inactive Ingredients (Ice Mint)

acesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, potassium aluminum silicate, sodium carbonate, xanthan gum

Questions Or Comments?

call toll-free 1-888-569-1743

Principal Display Panel

NDC 0135-0625-02

NEW

Nicorette

nicotine polacrilex lozenge, 2 mg •stop smoking aid

Lozenge

Coated

Ice Mint

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 Lozenge.

2 mg

80 LOZENGES, 2mg EACH

(4 Packs of 20)

Includes User’s Guide

TO INCREASE YOUR SUCCESS IN QUITTING:

1.You must be motivated to quit.
2.Use Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
3.Use Long Enough - Use Nicorette for the full 12 weeks.
4.Use With a Support Program as directed in the enclosed User’s Guide.

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

TO OPEN

PUSH

LIFT

TO CLOSE

Push Cap Closed until you hear a CLICK to ensure child resistance

CLICK

Distributed By:

GlaxoSmithKline Consumer Healthcare

Warren, NJ 07059

Made in the Switzerland

Trademarks are owned by or licensed to the GSK group of companies.

106600XA

NDC 0135-0626-02

NEW