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Nicorette Fruit Chill Prescribing Information

Package insert / product label
Generic name: nicotine polacrilex
Dosage form: chewing gum, Fruit Chill
Drug class: Smoking cessation agents

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 2 mg nicotine)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Indications and Usage for Nicorette Fruit Chill

  • 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.

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
  • history of seizures

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
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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.

Nicorette Fruit Chill Dosage and Administration

  • 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
  • begin using the gum on your quit day
  • if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine gum
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine gum 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. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Nicorette Fruit Chill Dosage and Administration

  • 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
  • begin using the gum on your quit day
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2mg nicotine gum
  • if you smoke your first cigarette within 30 minutes of waking up,use 4mg nicotine gum 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. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other information

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 -25 oC (68 - 77 oF)
  • protect from light

Inactive ingredients

each 4 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

Questions or comments?

call toll-free 1-800-419-4766

TO INCREASE YOUR SUCCESS IN QUITTING:

  • You must be motivated to quit.
  • Use Enough– Chew at least 9 piecesof Nicorette ®gum per day during the first six weeks.
  • Use Long Enough– Use Nicorette ®gum for the full 12 weeks.
  • Use with a support programas 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.

Distributed by

GlaxoSmithKlineConsumer Healthcare

Warren, NJ 07059

Made in Sweden

© 2016 GSK or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

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

Principal Display Panel

NDC 0135-0241-05

Nicorette ®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fruit Chill®

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

160 PIECES,2mg EACH

30856XG

30856XG_Nicorette Fruit Chill 2 mg_160 ct.JPG

Principal Display Panel

NDC 0135-0242-05

Nicorette ®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fruit Chill ®

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

160 PIECES,4 mg EACH

30857XG

30857XG_Nicorette Fruit Chill 4 mg_160 ct.JPG
NICORETTE FRUIT CHILL
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0241
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARESize15mm
FlavorFRUIT (fruit chill) Imprint CodeN2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0241-021 in 1 CARTON09/14/2009
1100 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0241-031 in 1 CARTON09/14/200908/01/2019
2190 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0241-051 in 1 CARTON09/14/2009
3160 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0241-061 in 1 CARTON09/14/2009
420 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0135-0241-0820 in 1 CARTON; Type 0: Not a Combination Product09/14/2009
6NDC:0135-0241-111 in 1 CARTON09/14/200908/01/2018
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:0135-0241-1425 in 1 CARTON; Type 0: Not a Combination Product09/14/200908/01/2018
8NDC:0135-0241-158 in 1 PACKAGE09/14/200908/01/2018
825 in 1 CARTON; Type 0: Not a Combination Product
9NDC:0135-0241-172 in 1 PACKAGE08/01/2014
910 in 1 CARTON
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:0135-0241-1812 in 1 CARTON09/01/2018
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:0135-0241-1918 in 1 CARTON12/03/2018
1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861209/14/2009
NICORETTE FRUIT CHILL
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0242
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
ACACIA (UNII: 5C5403N26O)
Product Characteristics
ColoryellowScoreno score
ShapeSQUARESize15mm
FlavorFRUIT (fruit chill) Imprint CodeN4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0242-021 in 1 CARTON09/14/2009
1100 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0242-031 in 1 CARTON09/14/200908/01/2019
2190 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0242-051 in 1 CARTON09/14/2009
3160 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0242-061 in 1 CARTON09/14/2009
420 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0135-0242-0820 in 1 CARTON; Type 0: Not a Combination Product09/14/2009
6NDC:0135-0242-111 in 1 CARTON09/14/2009
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:0135-0242-1425 in 1 CARTON; Type 0: Not a Combination Product09/14/200908/01/2018
8NDC:0135-0242-158 in 1 PACKAGE09/14/200908/01/2018
825 in 1 CARTON; Type 0: Not a Combination Product
9NDC:0135-0242-172 in 1 PACKAGE08/01/2014
910 in 1 CARTON
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:0135-0242-1812 in 1 CARTON09/01/2018
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:0135-0242-1918 in 1 CARTON12/03/2018
1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006609/14/2009
Labeler - Haleon US Holdings LLC (079944263)

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