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Name:Nicorettefruit Chill
Manufacturer:Glaxosmithkline Consumer Healthcare Lp
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NICORETTE FRUIT CHILL - nicotine gum, chewing 
GlaxoSmithKline Consumer Healthcare LP

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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.

Dosage and Administration 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 6 Weeks 7 to 9 Weeks 10 to 12
1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 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.

Dosage and Administration 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 6 Weeks 7 to 9 Weeks 10 to 12
1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 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.

    To remove the gum, tear off single unit.

    Peel off backing, starting at corner with loose edge.

    Push gum through foil.

  • 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

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

Questions or 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.

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.

©2009 GlaxoSmithKline

308571A

Principal Display Panel

Nicorette®

Nicotine polacrilex gum, 2mg stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fruit Chill™

2 mg

FOR THOSE WHO SMOKE LESS THAN 25 CIGARETTES A DAY

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

160 PIECES, 2mg EACH

Nicorette 2 mg Fruit Chill Carton

Principal Display Panel

Nicorette®

Nicotine polacrilex gum, 4mg stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fruit Chill™

4 mg

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

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

160 PIECES, 4mg EACH

Nicorette 4 mg Fruit Chill Carton


NICORETTE  FRUIT CHILL
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0241
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  
ACACIA  
ACESULFAME POTASSIUM  
CARNAUBA WAX  
HYPROMELLOSES  
MAGNESIUM OXIDE  
MENTHOL  
PEPPERMINT OIL  
POLYSORBATE 80  
SODIUM BICARBONATE  
SODIUM CARBONATE  
SUCRALOSE  
TITANIUM DIOXIDE  
XYLITOL  
Product Characteristics
Color WHITE Score no score
Shape SQUARE Size 15mm
Flavor FRUIT (fruit chill) Imprint Code N2
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0241-01 40 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
2 NDC:0135-0241-02 100 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
3 NDC:0135-0241-03 190 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
4 NDC:0135-0241-04 210 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
5 NDC:0135-0241-05 160 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
6 NDC:0135-0241-06 20 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 09/14/2009

NICORETTE  FRUIT CHILL
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0242
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  
CARNAUBA WAX  
D&C YELLOW NO. 10  
ALUMINUM OXIDE  
HYPROMELLOSES  
MAGNESIUM OXIDE  
MENTHOL  
PEPPERMINT OIL  
POLYSORBATE 80  
SODIUM CARBONATE  
SUCRALOSE  
TITANIUM DIOXIDE  
XYLITOL  
ACACIA  
Product Characteristics
Color YELLOW Score no score
Shape SQUARE Size 15mm
Flavor FRUIT (fruit chill) Imprint Code N4
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0242-01 40 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
2 NDC:0135-0242-02 100 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
3 NDC:0135-0242-05 160 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
4 NDC:0135-0242-03 190 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
5 NDC:0135-0242-04 210 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None
6 NDC:0135-0242-06 20 GUM, CHEWING ( PARTS) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 09/14/2009

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 02/2011 GlaxoSmithKline Consumer Healthcare LP



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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