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 (nicotine)

Active ingredient (in each lozenge) (4 mg)

Nicotine polacrilex, 4 mg (nicotine)

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

  • 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 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

Inactive ingredients

aspartame, magnesium stearate, mannitol, natural peppermint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, soy protein, xanthan gum

Questions or comments?

call toll-free 1-888-569-1743

Additional Information

TAMPER EVIDENT FEATURE:Do not use if printed inner safety seal under cap is broken or missing.

Retain outer carton for full product uses, directions and warnings.

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 ®Lozenges for the full 12 weeks.
  4. Use with a support programas directed in the enclosed User’s Guide.

Quit Tube ®

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

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

©2020 GSK group of companies or its licensor.

Principal Display Panel

NDC 0135-0635-01

Nicorette

nicotine polacrilex lozenge, 2 mg

stop smoking aid

Lozenge

Includes User’s Guide

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

Mint

72 LOZENGES,2 mg Each

(3 QuitTube ®Containers of 24)

45PB9SBC1-NRO – Front Carton

Nicorette mint lozenges 2mg 72 ct

Principal Display Panel

NDC 0135-0636-01

Nicorette

nicotine polacrilex lozenge, 4 mg

stop smoking aid

Lozenge

Includes User’s Guide

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.

Mint

72 LOZENGES,4 mg Each

(3 QuitTube ®Containers of 24)

84LB9SBC1-NRO – Front Carton

Nicorette mint lozenges 4mg 72 ct
NICORETTE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0635
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)  
ASPARTAME (UNII: Z0H242BBR1)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code L344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0635-013 in 1 CARTON06/01/2022
172 in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:0135-0635-026 in 1 CARTON06/01/2022
2144 in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133006/01/2022
NICORETTE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0636
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)  
ASPARTAME (UNII: Z0H242BBR1)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code L873
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0636-013 in 1 CARTON06/01/2022
172 in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:0135-0636-026 in 1 CARTON06/01/2022
2144 in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133006/01/2022
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 142b6b24-b7ed-5955-e063-6394a90aefe5
Set id: ffeb8286-860d-49f5-8df3-724afb4aaad8
Version: 2
Effective Time: 20240321
 
Haleon US Holdings LLC