NICORETTE- nicotine polacrilex lozenge 
Haleon US Holdings LLC

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Drug Facts

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

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.

Directions (2 mg)

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

Directions (4 mg)

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

Other information (Ice Mint)

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 WITHIN30 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 Lozengesper day during the first six weeks.
  3. Use Long Enough -Use Nicorette for the full 12 weeks.
  4. Use With a Support Programas 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 Closeduntil 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.

©2018 GSK group of companies or its licensor.

106600XA

106600XA_Nicorette Ice Mint_2 mg_80 Lozenges.JPG

Principal Display Panel

NDC 0135-0626-02

NEW

Nicorette

nicotine polacrilex lozenge, 4 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 MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Lozenge.

4 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 Lozengesper day during the first six weeks.
  3. Use Long Enough -Use Nicorette for the full 12 weeks.
  4. Use With a Support Programas 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 Closeduntil 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.

©2018 GSK group of companies or its licensor.

106608XA

106608XA_Nicorette Ice Mint_4 mg_80 Lozenges.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 Code n;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
POTASSIUM (UNII: RWP5GA015D)  
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
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)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize15mm
FlavorMINT (Ice Mint) Imprint Code n;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)

Revised: 7/2024
Document Id: 1ceab376-0b71-3bfb-e063-6394a90a4178
Set id: f350e050-2173-43e0-8738-848382ce0700
Version: 7
Effective Time: 20240710
 
Haleon US Holdings LLC