NICORETTE- nicotine polacrilex lozenge 
Haleon US Holdings LLC

----------

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 a 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 Lozenge)

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 Lozenge)

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

acesulfame potassium, calcium polycarbophil, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-888-569-1743

Principal Display Panel

NDC 0135-0508-02

Nicorette ®

nicotine polacrilex lozenge, 2 mg

stop smoking aid

miniLozenge

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 ®  4 mg Lozenge

81 LOZENGES,2 mg Each

(3 Vials of 27)

Opening Directions:

Push in child resistant tab on the vial with thumb.

Flip up the top of vial. Turn upside down and shake to remove lozenge.

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated to quit.
  2. Use Enough– Use at least 9 Nicorette®mini lozenges per day during the first six weeks.
  3. Use Long Enough– Use Nicorette®mini lozenges for the full 12 weeks.
  4. Use With a Support Programas directed in the enclosed User’s Guide.
  5. not for sale to those under 18 years of age
  6. proof of age required
  7. not for sale in vending machines or from any source where proof of age cannot be verified

TAMPER EVIDENT FEATURE:Do not use if clear neckband printed "SEALED FOR SAFETY" is missing or broken. Retain outer carton for full product uses, directions and warnings.

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

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

Distributed By:

GSKConsumer Healthcare

Warren, NJ 07059

Made in Switzerland

©2015 GSK group of companies or its licensor. All rights reserved.

104277XB

Nicorette Mini Lozenge 2 mg 81 ct carton

Principal Display Panel

NDC 0135-0509-02

Nicorette ®

nicotine polacrilex lozenge, 4mg

stop smoking aid

miniLozenge

Mint

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

81 LOZENGES,4 mg Each

(3 Vials of 27)

Opening Directions:

Push in child resistant tab on the vial with thumb.

Flip up the top of vial. Turn upside down and shake to remove lozenge.

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated to quit.
  2. Use Enough– Use at least 9 Nicorette®mini lozenges per day during the first six weeks.
  3. Use Long Enough– Use Nicorette®mini lozenges for the full 12 weeks.
  4. Use With a Support Programas directed in the enclosed User’s Guide.
  5. not for sale to those under 18 years of age
  6. proof of age required
  7. not for sale in vending machines or from any source where proof of age cannot be verified

TAMPER EVIDENT FEATURE:Do not use if clear neckband printed "SEALED FOR SAFETY" is missing or broken. Retain outer carton for full product uses, directions and warnings.

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

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

Distributed By:

GSKConsumer Healthcare

Warren, NJ 07059

Made in the Switzerland

©2015 GSK group of companies or its licensor. All rights reserved.

104255XB

Nicorette Mini Lozenge 4 mg 81 ct carton
NICORETTE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0508
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)  
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)  
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
ShapeOVALSize10mm
FlavorMINTImprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0508-023 in 1 CARTON03/01/2010
127 in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:0135-0508-035 in 1 CARTON03/01/2010
227 in 1 CONTAINER; Type 0: Not a Combination Product
3NDC:0135-0508-0420 in 1 CONTAINER; Type 0: Not a Combination Product03/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02236003/01/2010
NICORETTE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0509
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)  
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)  
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
ShapeOVALSize10mm
FlavorMINTImprint Code F
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0509-023 in 1 CARTON03/01/201008/31/2024
127 in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:0135-0509-035 in 1 CARTON03/01/201008/31/2024
227 in 1 CONTAINER; Type 0: Not a Combination Product
3NDC:0135-0509-0420 in 1 CONTAINER; Type 0: Not a Combination Product03/01/201008/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02236003/01/201008/31/2024
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 12f1fec8-003a-8788-e063-6394a90a298a
Set id: fdee1637-8049-4bc5-b196-b6d854c9f9f3
Version: 15
Effective Time: 20240305
 
Haleon US Holdings LLC