Wednesday, 28 March 2012

Nicotine Drug Facts





Dosage Form: lozenge
Drug Facts

Active 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 6Weeks 7 to 9Weeks 10 to 12
    1 lozenge every 1 to 2 hours1 lozenge every 2 to 4 hours1 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 feel 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 6Weeks 7 to 9Weeks 10 to 12
    1 lozenge every 1 to 2 hours1 lozenge every 2 to 4 hours1 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 feel 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

  • Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge

  • store at 20 – 25oC (68 – 77oF)

  • protect from light


Inactive ingredients


aspartame, calcium polycarbophil, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum



Questions or comments?


call toll-free 1-877-306-0019 (English/Spanish) weekdays (9:00 am – 4:30 pm ET)


Distributed by:


Walgreen Co.,


200 Wilmot Rd., Deerfield, IL 60015-4616


Quality Guaranteed 100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back.


www.walgreens.com


Compare to Commit®* Lozenge



Principal Display Panel


Nicotine Lozenge


Nicotine Polacrilex Lozenge, 4mg


STOP SMOKING AID


72 LOZENGES


4mg EACH


Includes User’s Guide


MINT FLAVOR


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 Nicotine Polacrilex Lozenge, 2mg


  • 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

This product is protected in sealed blisters.


Do not use if individual blisters or printed backings are broken, open or torn.


TO INCREASE YOUR SUCCESS IN QUITTING:


  1. You must be motivated to quit.

  2. Use Enough – Use at least 9 lozenges per day during the first six weeks.

  3. Use Long Enough – Use for the full 12 weeks.

  4. Use With a Support Program as directed in the enclosed User’s Guide.

To remove the lozenge, tear off single unit.


Peel off backing starting at corner with loose edge.


Push lozenge through foil.


Comments/questions:


GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398, Research Triangle Park, NC 27709-9627


30822XA


©2009




Principal Display Panel


Nicotine Lozenge


Nicotine Polacrilex Lozenge, 2mg


STOP SMOKING AID


72 LOZENGES


2mg EACH


Includes User’s Guide


MINT 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 Nicotine Polacrilex Lozenge, 4mg


  • 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

This product is protected in sealed blisters.


Do not use if individual blisters or printed backings are broken, open or torn.


TO INCREASE YOUR SUCCESS IN QUITTING:


  1. You must be motivated to quit.

  2. Use Enough – Use at least 9 lozenges per day during the first six weeks.

  3. Use Long Enough – Use for the full 12 weeks.

  4. Use With a Support Program as directed in the enclosed User’s Guide.

To remove the lozenge, tear off single unit.


Peel off backing starting at corner with loose edge.


Push lozenge through foil.


Comments/questions:


GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398, Research Triangle Park, NC 27709-9627


30821XA


© 2009










NICOTINE 
nicotine  lozenge










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0363-0208
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE)NICOTINE2 mg






















Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
MAGNESIUM STEARATE 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
XANTHAN GUM 


















Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint CodePL2
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10363-0208-0172 LOZENGE In 1 CONTAINERNone
20363-0208-07108 LOZENGE In 1 CONTAINERNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133010/31/2002







NICOTINE 
nicotine  lozenge










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0363-0209
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE)NICOTINE4 mg






















Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ASPARTAME 
CALCIUM POLYCARBOPHIL 
MAGNESIUM STEARATE 
MANNITOL 
POTASSIUM BICARBONATE 
SODIUM ALGINATE 
SODIUM CARBONATE 
XANTHAN GUM 


















Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize16mm
FlavorMINTImprint CodePL4
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10363-0209-0172 LOZENGE In 1 CONTAINERNone
20363-0209-07108 LOZENGE In 1 CONTAINERNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02133010/31/2002


Labeler - Walgreens (008965063)
Revised: 09/2010Walgreens




More Nicotine Drug Facts resources


  • Nicotine Drug Facts Side Effects (in more detail)
  • Nicotine Drug Facts Use in Pregnancy & Breastfeeding
  • Nicotine Drug Facts Drug Interactions
  • Nicotine Drug Facts Support Group
  • 42 Reviews for Nicotine Drug Facts - Add your own review/rating


Compare Nicotine Drug Facts with other medications


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