Label: NICORETTE- nicotine polacrilex lozenge
- NDC Code(s): 0135-1500-01, 0135-1500-02, 0135-2800-01, 0135-2800-02
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 25, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each lozenge) (2 mg)
- Active ingredient (in each lozenge) (4 mg)
- Purpose
- Use
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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.
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- stomach ulcer or diabetes
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- history of seizures
Ask a doctor or pharmacist before use if you are
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- using a non-nicotine stop smoking drug
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- taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
Stop use and ask a doctor if
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- mouth problems occur
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- persistent indigestion or severe sore throat occurs
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- irregular heartbeat or palpitations occur
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- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
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- you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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Directions (2 mg Lozenge)
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- 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
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- 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
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- 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
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- 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
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- 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.
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Directions (4 mg Lozenge)
- •
- 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
- Inactive ingredients
- Questions or comments?
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Additional Information
- 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 program as directed in the enclosed User’s Guide.
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: 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.com or see inside for more details.
Opening Directions:
Squeeze child resistant tabs on each side. Flup up the top of vial. Turn upside down and shake to remove lozenge.
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Principal Display Panel
NDC 0135-2800-02
NICORETTE
nicotine polacrilex lozenge, 2 mg
stop smoking aid
mini Lozenge
2 mg
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 Nicorette4 mg Lozenge.
NEW VIAL & OPENING DIRECTIONS
81 LOZENGES, 2 mg EACH
(3 Vials of 27)
Mint
-
Principal Display Panel
NDC 0135-1500-02
NICORETTE
nicotine polacrilex lozenge, 4 mg
stop smoking aid
mini Lozenge
4 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.
If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette2 mg Lozenge.
NEW VIAL & OPENING DIRECTIONS
81 LOZENGES, 4 mg EACH
(3 Vials of 27)
Mint
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INGREDIENTS AND APPEARANCE
NICORETTE
nicotine polacrilex lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-2800 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 2 mg Inactive Ingredients Ingredient Name Strength 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) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 10mm Flavor MINT Imprint Code L734 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-2800-01 20 in 1 CONTAINER; Type 0: Not a Combination Product 06/01/2022 2 NDC:0135-2800-02 3 in 1 CARTON 06/01/2022 2 27 in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022360 06/01/2022 NICORETTE
nicotine polacrilex lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-1500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 4 mg Inactive Ingredients Ingredient Name Strength 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) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 10mm Flavor MINT Imprint Code L957 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-1500-01 20 in 1 CONTAINER; Type 0: Not a Combination Product 06/01/2022 2 NDC:0135-1500-02 3 in 1 CARTON 06/01/2022 2 27 in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022360 06/01/2022 Labeler - Haleon US Holdings LLC (079944263)
