COMMIT
-
nicotine lozenge
GlaxoSmithKline Consumer Healthcare LP
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Drug FactsActive ingredient (in each lozenge)
Nicotine polacrilex, 4 mg
Nicotine polacrilex, 2 mg
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 product
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
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 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 (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
- you may fell a warm or tingling sensation
- occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 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 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 (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
- you may fell a warm or tingling sensation
- occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 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, 18 mg
- store at 20 – 25oC (68 – 77oF)
- keep POPPAC tightly closed and protect from light
Inactive ingredients
acesulfame potassium, benzyl alcohol, butylhydroxy toluene, calcium polycarbophil, coconut and/or palm kernel oil, eugenol, flavors, magnesium stearate, maltodextrin, mannitol, modified corn starch, 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.
©2008 GlaxoSmithKline
Principal Display Panel
Commit®
Nicotine polacrilex lozenge, 4mg
STOP SMOKING AID
108 LOZENGES
(4 PoppacTM Containers of 27)
4mg EACH
FROM THE MARKETERS OF NICORETTE®
CHERRY FLAVOR
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 Commit® 2mg Lozenge
- 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.
COMMIT®, COMMITTED QUITTERS®, POPPACTM, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies.
TO INCREASE YOUR SUCCESS IN QUITTING:
- You must be motivated to quit.
- Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks.
- Use Long Enough – Use Commit for the full 12 weeks.
- Use With a Support Program as directed in the enclosed User’s Guide.
Commit® POPPACTM
To open vial, push in child resistant band on the POPPACTM with thumb.
Flip up the top of the POPPACTM and remove lozenge. A small amount of powder on opening of the POPPACTM is normal.
go to www.commitlozenge.com for online support program
Principal Display Panel
Commit®
Nicotine polacrilex lozenge, 2mg
STOP SMOKING AID
108 LOZENGES
(4 PoppacTM Containers of 27)
2mg EACH
FROM THE MARKETERS OF NICORETTE®
Includes User’s Guide
CHERRY FLAVOR
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 Commit® 4mg Lozenge
- 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.
COMMIT®, COMMITTED QUITTERS®, POPPACTM, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies.
TO INCREASE YOUR SUCCESS IN QUITTING:
- You must be motivated to quit.
- Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks.
- Use Long Enough – Use Commit for the full 12 weeks.
- Use With a Support Program as directed in the enclosed User’s Guide.
Commit® POPPACTM
To open vial, push in child resistant band on the POPPACTM with thumb.
Flip up the top of the POPPACTM and remove lozenge. A small amount of powder on opening of the POPPACTM is normal.
go to www.commitlozenge.com for online support program
| COMMIT
nicotine polacrilex lozenge |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021330 | 11/22/2005 | |
| COMMIT
nicotine polacrilex lozenge |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021330 | 11/22/2005 | |
| Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625) |