Thursday, October 6, 2016

Nicorette White Ice



nicotine polacrilex

Dosage Form: gum, chewing
Drug Facts

Active Ingredient ( in each chewing piece)


Nicotine polacrilex (equal to 2mg nicotine)


Nicotine polacrilex (equal to 4mg nicotine)



Purpose


Stop smoking aid



Use


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


  • 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 blood pressure.

  • stomach ulcer or diabetes


Ask a doctor or a 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, teeth or jaw problems occur

  • 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.


 Pieces of  nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.



Directions 2mg


  • 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 gum

  • if you smoke 25 or more cigarettes a day; use 4mg nicotine gum

  • if you smoke less than 25 cigarettes a day; use according to the following 12 week schedule:








Weeks 1 to 6Weeks 7 to 9Weeks 10 to 12
1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 piece every 4 to 8 hours
  • nicotine gum is a medicine and must be used a certain way to get the best results

  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.

  • repeat this process until most of the tingle is gone (about 30 minutes)

  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.

  • do not use more than 24 pieces a day

  • it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.


Directions 4 mg


  • 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 gum

  • if you smoke less than 25 cigarettes a day; use 2mg nicotine gum

  • if you smoke 25 or more cigarettes a day; use according to the following 12 week schedule:








Weeks 1 to 6Weeks 7 to 9Weeks 10 to 12
1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 piece every 4 to 8 hours
  • nicotine gum is a medicine and must be used a certain way to get the best results

  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.

  • repeat this process until most of the tingle is gone (about 30 minutes)

  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.

  • do not use more than 24 pieces a day

  • it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.

 


TO INCREASE YOUR SUCCESS IN QUITTING:


  1. You must be motivated to quit.

  2. Use Enough – Chew at least 9 pieces of Nicorette per day during the first six weeks.

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

  4. Use with a support program as directed in the enclosed User’s Guide.

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.


Free Audio CD upon request. See inside.


To remove the gum, tear off single unit.


Push gum through foil.


Peel off backing, starting at corner with loose edge.


  • 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.



Other information:


  • each 2 mg piece contains: calcium 94 mg, sodium 11 mg

  • each 4 mg piece contains: calcium 94 mg, sodium 13 mg

  • store at 20 - 25oC (68 - 77oF)

  • protect from light


Inactive Ingredients White Ice Mint


each 2 mg piece contains: acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol


each 4 mg piece contains: acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol



Inactive Ingredients Original


each 2 mg piece contains: flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol


each 4 mg piece contains: D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol



Inactive Ingredients Cinnamon Surge


each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol


each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol



Inactive Ingredients Fresh Mint


each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol


each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, titanium dioxide, xylitol



Inactive Ingredients Mint


each 2 mg piece contains: acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol


each 4 mg piece contains: acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol



Questions and comments?


call toll-free 1-800-419-4766 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)


Distributed by


GlaxoSmithKline Consumer Healthcare, L.P.


Moon Township, PA 15108


Made in Sweden


NICORETTE is a registered trademark of the GlaxoSmithKline group of companies.


©2009 GlaxoSmithKline



Principal Display Panel


Nicorette®


nicotine polacrilex gum, 2mg stop smoking aid


Gum


Coated


FOR BOLD FLAVOR


White Ice Mint®


2 mg


FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY


If you smoke 25 or more cigarettes a day: use Nicorette 4mg


40 PIECES, 2mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 4mg stop smoking aid


Gum


WHITENS TEETH


Coated


FOR BOLD FLAVOR


White Ice Mint®


4 mg


FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY


If you smoke less than 25 cigarettes a day: use Nicorette 2mg


40 PIECES, 4mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 2mg stop smoking aid


Gum


Original 


2 mg


FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY


If you smoke 25 or more cigarettes a day: use Nicorette 4mg


110 PIECES, 2mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 4mg stop smoking aid


Gum


Original


4 mg


FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY


If you smoke less than 25 cigarettes a day: use Nicorette 2mg


110 PIECES, 4mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 2mg stop smoking aid


Gum


Coated


FOR BOLD FLAVOR


Cinnamon SurgeTM


2 mg


FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY


If you smoke 25 or more cigarettes a day: use Nicorette 4mg


110 PIECES, 2mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 4mg stop smoking aid


Gum


Coated


FOR BOLD FLAVOR


Cinnamon SurgeTM


4 mg


FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY


If you smoke less than 25 cigarettes a day: use Nicorette 2mg


110 PIECES, 4mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 2mg stop smoking aid


Gum


Coated


FOR BOLD FLAVOR


Fresh MintTM


2 mg


FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY


If you smoke 25 or more cigarettes a day: use Nicorette 4mg


100 PIECES, 2mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 4mg stop smoking aid


Gum


Coated


FOR BOLD FLAVOR


Fresh MintTM


4 mg


FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY


If you smoke less than 25 cigarettes a day: use Nicorette 2mg


100 PIECES, 4mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 2mg stop smoking aid


Gum


Mint


2 mg


FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY


If you smoke 25 or more cigarettes a day: use Nicorette 4mg


110 PIECES, 2mg EACH




Principal Display Panel


Nicorette®


nicotine polacrilex gum, 4mg stop smoking aid


Gum


Mint 


4 mg


FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY


If you smoke less than 25 cigarettes a day: use Nicorette 2mg


110 PIECES, 4mg EACH










NICORETTE  WHITE ICE MINT
nicotine polacrilex  gum, chewing










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0474
Route of AdministrationORALDEA Schedule    








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






























Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ACESULFAME POTASSIUM 
CARNAUBA WAX 
HYPROMELLOSE 
MAGNESIUM OXIDE 
MENTHOL 
PEPPERMINT OIL 
POLYSORBATE 80 
SODIUM BICARBONATE 
SODIUM CARBONATE 
SUCRALOSE 
TITANIUM DIOXIDE 
XYLITOL 


















Product Characteristics
ColorWHITEScoreno score
ShapeSQUARESize15mm
FlavorMINT (White Ice Mint)Imprint CodeN2
Contains      


































Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0474-0120 PARTS In 1 BLISTER PACKNone
20135-0474-0740 PARTS In 1 BLISTER PACKNone
30135-0474-02100 PARTS In 1 BLISTER PACKNone
40135-0474-05160 PARTS In 1 BLISTER PACKNone
50135-0474-03190 PARTS In 1 BLISTER PACKNone
60135-0474-04210 PARTS In 1 BLISTER PACKNone
70135-0474-06120 PARTS In 1 BLISTER PACKNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009







NICORETTE  WHITE ICE MINT
nicotine polacrilex  gum, chewing










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0475
Route of AdministrationORALDEA Schedule    








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
































Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ACESULFAME POTASSIUM 
CARNAUBA WAX 
D&C YELLOW NO. 10 
ALUMINUM OXIDE 
HYPROMELLOSE 
MAGNESIUM OXIDE 
MENTHOL 
PEPPERMINT OIL 
POLYSORBATE 80 
SODIUM CARBONATE 
SUCRALOSE 
TITANIUM DIOXIDE 
XYLITOL 


















Product Characteristics
ColorWHITE (cream)Scoreno score
ShapeSQUARESize15mm
FlavorMINT (White Ice Mint)Imprint CodeN4
Contains      


































Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0475-0120 PARTS In 1 BLISTER PACKNone
20135-0475-0740 PARTS In 1 BLISTER PACKNone
30135-0475-02100 PARTS In 1 BLISTER PACKNone
40135-0475-05160 PARTS In 1 BLISTER PACKNone
50135-0475-03190 PARTS In 1 BLISTER PACKNone
60135-0475-04210 PARTS In 1 BLISTER PACKNone
70135-0475-06120 PARTS In 1 BLISTER PACKNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006606/29/2009







NICORETTE  ORIGINAL
nicotine polacrilex  gum, chewing










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0157
Route of AdministrationORALDEA Schedule    








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














Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
GLYCERIN 
SODIUM BICARBONATE 
SODIUM CARBONATE 
SORBITOL 


















Product Characteristics
ColorWHITE (beige)Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains      


























Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0157-0950 PARTS In 1 BLISTER PACKNone
20135-0157-07110 PARTS In 1 BLISTER PACKNone
30135-0157-10170 PARTS In 1 BLISTER PACKNone
40135-0157-11200 PARTS In 1 BLISTER PACKNone
50135-0157-12220 PARTS In 1 BLISTER PACKNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009







NICORETTE  ORIGINAL
nicotine polacrilex  gum, chewing










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0158
Route of AdministrationORALDEA Schedule    








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














Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
D&C YELLOW NO. 10 
GLYCERIN 
SODIUM CARBONATE 
SORBITOL 


















Product Characteristics
ColorWHITE (beige)Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains      


























Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0158-0950 PARTS In 1 BLISTER PACKNone
20135-0158-07110 PARTS In 1 BLISTER PACKNone
30135-0158-10170 PARTS In 1 BLISTER PACKNone
40135-0158-11200 PARTS In 1 BLISTER PACKNone
50135-0158-12220 PARTS In 1 BLISTER PACKNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006606/29/2009







NICORETTE  CINNAMON SURGE
nicotine polacrilex  gum, chewing










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0466
Route of AdministrationORALDEA Schedule    








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
































Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ACACIA 
ACESULFAME POTASSIUM 
CARNAUBA WAX 
HYPROMELLOSE 
MAGNESIUM OXIDE 
MENTHOL 
PEPPERMINT OIL 
POLYSORBATE 80 
SODIUM BICARBONATE 
SODIUM CARBONATE 
SUCRALOSE 
TITANIUM DIOXIDE 
XYLITOL 


















Product Characteristics
ColorWHITEScoreno score
ShapeSQUARESize15mm
FlavorCINNAMONImprint CodeN2
Contains      


































Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0466-0120 PARTS In 1 BLISTER PACKNone
20135-0466-0740 PARTS In 1 BLISTER PACKNone
30135-0466-02100 PARTS In 1 BLISTER PACKNone
40135-0466-05160 PARTS In 1 BLISTER PACKNone
50135-0466-03190 PARTS In 1 BLISTER PACKNone
60135-0466-04120 PARTS In 1 BLISTER PACKNone
70135-0466-06210 PARTS In 1 BLISTER PACKNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009






NICORETTE  CINNAMON SURGE
nicotine polacrilex  gum, chewing










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0135-0467
Route of AdministrationORALDEA Schedule    








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


































Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ACACIA 
ACESULFAME POTASSIUM 
CARNAUBA WAX 
D&C YELLOW NO. 10 
ALUMINUM OXIDE 
HYPROMELLOSE 
MAGNESIUM OXIDE 
MENTHOL 
PEPPERMINT OIL 
POLYSORBATE 80 
SODIUM CARBONATE 
SUCRALOSE 
TITANIUM DIOXIDE 
XYLITOL 


















Product Characteristics
ColorWHITE (cream)Scoreno score
ShapeSQUARESize15mm
FlavorCINNAMONImprint CodeN4
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0467-0120 PARTS In 1 BLISTER PACKNone
20135-0467-02100 PARTS In 1 BLISTER PACKNone
30135-0467-03190 PARTS In 1 BLISTER PACKNone
40135-0467-04120 PARTS In 1 BLISTER PACKNone
50135-0467-05160 PARTS In 1 BLISTER PACKNone
60135-0467-06210 PARTS In 1 BLISTER PACKNone

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