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Nicorette Lozenge: Package Insert / Prescribing Info

Package insert / product label
Generic name: nicotine polacrilex
Dosage form: oral lozenge
Drug class: Smoking cessation agents

Medically reviewed by Drugs.com. Last updated on Jun 8, 2025.

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

Indications and Usage for Nicorette Lozenge

  • 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

  • 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.

Nicorette Lozenge Dosage and Administration

  • 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.

Nicorette Lozenge Dosage and Administration

  • 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.

Related/similar drugs

Storage and Handling

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

Inactive ingredients

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

Questions or comments?

call toll-free 1-888-569-1743

Additional Information

  • 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

TAMPER EVIDENT FEATURE:The lozenge container is protected in a clear plastic shell, sealed to a printed card.

Do not use if the printed card or plastic shell is torn or broken, or if there is any evidence that the printed card was separated from the plastic shell.

Retain this package for complete product information.

Includes Quit Support Program

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.comor 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:

Haleon

Warren, NJ 07059

Made in the Switzerland

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

©2023 Haleon group of companies or its licensor.

Principal Display Panel

NDC 0135-0625-01

HALEON

NICORETTE

nicotine polacrilex lozenge, 2 mg ׀ stop smoking aid

Lozenge

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 Lozenge.

SUGAR FREE

20 LOZENGES, 2 mg EACH(1 Pack of 20)

Includes User’s Guide

Coated Ice Mint

216965

216965 Nicorette Mini Lozenge 2 mg 20 ct.jpg

Principal Display Panel

NDC 0135-0626-01

HALEON

NICORETTE

nicotine polacrilex lozenge, 4 mg ׀ stop smoking aid

Lozenge

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 Lozenge.

SUGAR FREE

20 LOZENGES, 4 mg EACH(1 Pack of 20)

Includes User’s Guide

Coated Ice Mint

216969

216969 Nicorette Mini Lozenge 4 mg 20 ct.jpg
NICORETTE
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0625
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM (UNII: RWP5GA015D)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize15mm
FlavorMINT (Ice Mint) Imprint Coden;2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0625-011 in 1 CARTON04/11/2019
120 in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:0135-0625-024 in 1 CARTON04/11/2019
220 in 1 CONTAINER; Type 0: Not a Combination Product
3NDC:0135-0625-036 in 1 CARTON10/23/2019
320 in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133004/11/2019
NICORETTE
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0626
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM (UNII: RWP5GA015D)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize15mm
FlavorMINT (Ice Mint) Imprint Coden;4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0626-011 in 1 CARTON04/11/2019
120 in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:0135-0626-024 in 1 CARTON04/11/2019
220 in 1 CONTAINER; Type 0: Not a Combination Product
3NDC:0135-0626-036 in 1 CARTON10/23/2019
320 in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133004/11/2019
Labeler - Haleon US Holdings LLC (079944263)

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