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nicotine by Hannaford Brothers Company

Dosage form: gum, chewing
Ingredients: NICOTINE 4mg
Labeler: Hannaford Brothers Company
NDC Code: 41268-532

Hannaford Bros. Co. Nicotine Polacrilex Gum 4 mg (nicotine) Drug Facts

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 mg nicotine)

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 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 pharmacist before use if you are
  • using a non-nicotine stop smoking drug
  • taking prescription medication 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 or 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
  • 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 Nicotine Polacrilex Gum, 2 mg
  • 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 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 tingling 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.

Other information
  • each piece contains: calcium 100 mg and sodium 11 mg
  • store at 20-25°C (68-77°F)
  • protect from light

Inactive ingredients

acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, flavors, gelatin, gum base, mannitol, sodium bicarbonate, sodium carbonate, sorbitol, talc, titanium dioxide, xylitol

Questions or comments?

call 1-866-677-7858

Consumer Information

Principal Display Panel

Compare to Nicorette® Fresh Mint Coated Gum active ingredient

Nicotine Polacrilex Gum 4 mg (nicotine)

Stop Smoking Aid

FOR THOSE WHO SMOKE 25 OR MORE CIGARETTES A DAY

If you smoke less than 25 cigarettes a day: use Nicotine Polacrilex Gum, 2 mg

4mg

Coated for EXTREME FLAVOR

Coated Gum

ACTUAL SIZE

Cool Mint

4 mg EACH

Nicotine Polacrilex Gum 4 mg (nicotine) Carton Image 1

Nicotine Polacrilex Gum 4 mg (nicotine) Carton Image 2

NICOTINE 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41268-532
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CALCIUM CARBONATE 
CARNAUBA WAX 
D&C YELLOW NO. 10 
GELATIN 
MANNITOL 
SODIUM BICARBONATE 
SODIUM CARBONATE 
SORBITOL 
TALC 
TITANIUM DIOXIDE 
XYLITOL 
POLACRILIN 
Product Characteristics
ColorYELLOW (light;coated) Scoreno score
ShapeRECTANGLESize16mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41268-532-7810 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 GUM, CHEWING (PIECE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07677902/16/2009
Labeler - Hannaford Brothers Company (006949556)

Revised: 02/2012
 
Hannaford Brothers Company

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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