Nicorette Drugs Facts

Pronunciation

Generic Name: nicotine polacrilex
Dosage Form: lozenge

Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg

Nicotine polacrilex, 2 mg

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Purpose

Stop smoking aid

Uses

  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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.

Do not use

  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

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

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

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 4mg Lozenge

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • stop smoking completely when you begin using the lozenge
  • if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge
  • if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge according to the following 12 week schedule:
Weeks 1to 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 (about 10 minutes). 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 (about 10 minutes)
  • 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.
  • stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Directions 2mg Lozenge

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • stop smoking completely when you begin using the lozenge
  • if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge
  • if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge according to the following 12 week schedule:
  • Weeks 1to 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 (about 10 minutes). 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 (about 10 minutes)
  • 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.
  • stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information

  • Each lozenge contains: sodium, 5 mg
  • store at 20 – 25oC (68 – 77oF)
  • keep vial tightly closed and protect from light

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 (English/Spanish) weekdays (9:00 am – 4:30 pm ET)

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in the U.K.

©2009 GlaxoSmithKline

Flip open for Directions and additional information

Retain this package for complete product information

  • 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

NICORETTE®, COMMITTED QUITTERS®, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to the GlaxoSmithKline group of companies.

Opening Direction:

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 Program as directed in the enclosed User’s Guide.

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

go to www.nicorette.com for online support program

Principal Display Panel

Nicorette®

Nicotine polacrilex lozenge, 4mg

stop smoking aid

24 LOZENGES

mini Lozenge

4mg EACH (1 vial of 24)

Includes User’s Guide

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 Nicorette 2mg Lozenge

Principal Display Panel

Nicorette®

Nicotine polacrilex lozenge, 2mg

stop smoking aid

24 LOZENGES

mini Lozenge

2mg EACH (1 Vial of 24)

Includes User’s Guide

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 Nicorette® 4mg Lozenge

NICORETTE 
nicotine lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0508
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN  
ACESULFAME POTASSIUM  
CALCIUM POLYCARBOPHIL  
MAGNESIUM STEARATE  
MANNITOL  
POTASSIUM BICARBONATE  
SODIUM ALGINATE  
SODIUM CARBONATE  
XANTHAN GUM  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 10mm
Flavor MINT Imprint Code M
Contains         
Packaging
# Item Code Package Description
1 NDC:0135-0508-01 24 LOZENGE (LOZENGE) in 1 CONTAINER
2 NDC:0135-0508-02 3 CONTAINER (CONTAINER) in 1 CARTON
2 27 LOZENGE (LOZENGE) in 1 CONTAINER
3 NDC:0135-0508-03 5 CONTAINER (CONTAINER) in 1 CARTON
3 27 LOZENGE (LOZENGE) in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022360 03/01/2010
NICORETTE 
nicotine lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0509
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN  
ACESULFAME POTASSIUM  
CALCIUM POLYCARBOPHIL  
MAGNESIUM STEARATE  
MANNITOL  
POTASSIUM BICARBONATE  
SODIUM ALGINATE  
SODIUM CARBONATE  
XANTHAN GUM  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 10mm
Flavor MINT Imprint Code F
Contains         
Packaging
# Item Code Package Description
1 NDC:0135-0509-01 24 LOZENGE (LOZENGE) in 1 CONTAINER
2 NDC:0135-0509-02 3 CONTAINER (CONTAINER) in 1 CARTON
2 27 LOZENGE (LOZENGE) in 1 CONTAINER
3 NDC:0135-0509-03 5 CONTAINER (CONTAINER) in 1 CARTON
3 27 LOZENGE (LOZENGE) in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022360 03/01/2010
Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)
Revised: 05/2010
 
GlaxoSmithKline Consumer Healthcare LP



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