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Name:Nicotine Polacrilex
Manufacturer:Ivax Pharmaceuticals Inc
Category:Over-the-counter (OTC) Marketed Drugs


NICOTINE POLACRILEX - nicotine gum, chewing 
IVAX Pharmaceuticals Inc

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Drug Facts

Active Ingredient (in each chewing piece)

Nicotine polacrilex USP (equal to 4 mg nicotine)

Purpose

Stop Smoking Aid

Use

  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

Warnings

If you are pregnant or breastfeeding, only use this medicine on the advice of your healthcare 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 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 heart beat 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

  • 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 2 mg 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.

Other Information

  • each piece contains: calcium 61 mg, sodium 8.44 mg
  • Store at 20° to 25°C (68° to 77°F)
  • Protect from light

Inactive Ingredients

corn starch, D&C yellow #10, gum base, noncrystallizing sorbitol solution, peppermint oil, sodium bicarbonate, sodium carbonate, sorbitol

Questions or comments?

call TEVA Pharmaceuticals USA Medical Affairs Department at 1-888-838-2872 weekdays (8:30 a.m. to 5:00 p.m. EST).

PRINCIPAL DISPLAY PANEL - 4 mg Carton

NDC 0172-6731-27
Compare to the active ingredient in Nicorette®

NICOTINE POLACRILEX
GUM USP
4 mg
(nicotine)
Original

Stop Smoking Aid

Starter Kit: Includes stop smoking plan with User's Guide

For those who smoke 25 or more cigarettes a day

If you smoke less than 25 cigarettes a day: use nicotine polacrilex gum USP 2 mg

Free Audio CD upon
request. See inside.

108 Pieces, 4 mg Each

TEVA

PRINCIPAL DISPLAY PANEL - 4 mg Carton

NICOTINE POLACRILEX 
nicotine gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0172-6731
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
STARCH, CORN  
PEPPERMINT OIL  
SODIUM BICARBONATE  
SORBITOL  
SODIUM CARBONATE  
D&C YELLOW NO. 10  
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 17mm
Flavor PEPPERMINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0172-6731-27 108 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK (0172-6731-00)
1 NDC:0172-6731-00 1 GUM, CHEWING ( STICK) in 1 BLISTER PACK This package is contained within the BOX (0172-6731-27)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077850 11/15/2010

Labeler - IVAX Pharmaceuticals Inc (884075235)
Establishment
Name Address ID/FEI Operations
Anderson Packaging, Inc. 053217022 PACK

Revised: 11/2010 IVAX Pharmaceuticals Inc



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


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