Label: NICORETTE- nicotine polacrilex lozenge
-
NDC Code(s):
0135-0625-01,
0135-0625-02,
0135-0625-03,
0135-0626-01, view more0135-0626-02, 0135-0626-03
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 10, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- 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
-
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)
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Directions (2 mg)
- 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.
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Directions (4 mg)
- 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 (Ice Mint)
- Inactive ingredients (Ice Mint)
- Questions or comments?
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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:
- You must be motivated to quit.
- Use Enough -Use at least 9 Nicorette Lozengesper day during the first six weeks.
- Use Long Enough -Use Nicorette for the full 12 weeks.
- 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
-
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:
- You must be motivated to quit.
- Use Enough -Use at least 9 Nicorette Lozengesper day during the first six weeks.
- Use Long Enough -Use Nicorette for the full 12 weeks.
- 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
-
INGREDIENTS AND APPEARANCE
NICORETTE
nicotine polacrilex lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0625 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) 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 Color white (white to off-white) Score no score Shape OVAL Size 15mm Flavor MINT (Ice Mint) Imprint Code n;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0625-01 1 in 1 CARTON 04/11/2019 1 20 in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:0135-0625-02 4 in 1 CARTON 04/11/2019 2 20 in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:0135-0625-03 6 in 1 CARTON 10/23/2019 3 20 in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021330 04/11/2019 NICORETTE
nicotine polacrilex lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0626 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 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 Color white (white to off-white) Score no score Shape OVAL Size 15mm Flavor MINT (Ice Mint) Imprint Code n;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0626-01 1 in 1 CARTON 04/11/2019 1 20 in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:0135-0626-02 4 in 1 CARTON 04/11/2019 2 20 in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:0135-0626-03 6 in 1 CARTON 10/23/2019 3 20 in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021330 04/11/2019 Labeler - Haleon US Holdings LLC (079944263)