Label: NICORETTE FRUIT CHILL NICOTINE POLACRILEX- nicotine gum, chewing
- NDC Code(s): 29485-5270-1
- Packager: Mechanical Servants LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 29, 2019
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewing piece)
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 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)
- 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 2 mg nicotine gum
if you smoke your first cigarette within 30 minutes of waking up, use 4 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.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 10 Piece Blister Pack Carton
This package size may not be
a full day's supply; it is intended
to start or continue a quit attempt.
nicotine polacrilex gum, 4 mg • stop smoking aid
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 Nicorette® 2 mg Gum
FOR BOLD FLAVOR
10 PIECES, 4 mg EACH
INGREDIENTS AND APPEARANCE
NICORETTE FRUIT CHILL NICOTINE POLACRILEX
nicotine gum, chewing
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29485-5270 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R) Nicotine 4 mg Inactive Ingredients Ingredient Name Strength 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 Color YELLOW Score no score Shape SQUARE Size 15mm Flavor FRUIT Imprint Code N4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29485-5270-1 1 in 1 CARTON 09/14/2009 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020066 09/14/2009 Labeler - Mechanical Servants LLC (005530951) Establishment Name Address ID/FEI Business Operations Mechanical Servants LLC 005530951 REPACK(29485-5270) , RELABEL(29485-5270) Establishment Name Address ID/FEI Business Operations GlaxoSmithKline 046877908 MANUFACTURE(29485-5270)