Nicotine Polacrilex, Original description, usages, side effects, indications, overdosage, supplying and lots more!

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Nicotine Polacrilex, Original

Chain Drug Marketing Association Inc.

Nicotine Polacrilex Gum - Quality Choice - Original




FULL PRESCRIBING INFORMATION

Nicotine Polacrilex 2 mg (nicotine)
Nicotine Polacrilex 4 mg (nicotine)

Stop smoking aid

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

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.

  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products
  • 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
  • using a non-nicotine stop smoking drug
  • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. 
  • 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)

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.

  • 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 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. 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.
  • 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 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. 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.
  • (2 mg) each piece contains: calcium 115 mg, sodium 11 mg
  • (4 mg) each piece contains: calcium 110 mg, sodium 11 mg
  • store at 20 - 25ºC (68 - 77ºF)
  • protect from light

acesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.

acesulfame potassium, butylated hydroxytoluene, carnauba wax, D&C yellow # 10 lake, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.

Call 1-877-440-7867

Nicotine Polacrilex, Original

To remove the gum, tear off single unit.

Peel off backing starting at corner with loose edge.

Push gum through foil.

TO INCREASE YOUR SUCCESS IN QUITTING:

  • You must be motivated to quit.
  • Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.
  • Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.
  • Use with a Support Program as directed in the enclosed User's Guide.

Blister packaged for your protection.
Do not use if individual seals are open or torn.

  • 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 not manufactured or distributed
by GlaxoSmithKline Consumer Healthcare, L.P.
owner of the registered trademark Nicorrette®

Quality Choice                                       
NDC 63868-196-11

COMPARE TO THE ACTIVE INGREDIENT 
IN NICORETTE®

NICOTINE
Polacrilex
GUM USP, 
2 mg (nicotine)

STOP SMOKING AID

Nicotine Polacrilex, 2 mg
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Gum USP, 4 mg

2 mg        
Original

110 pieces (2 mg Each)

Nicotine Polacrilex, Original

Quality Choice                                       
NDC 63868-195-11

*COMPARE TO THE ACTIVE INGREDIENT 
IN NICORETTE®

NICOTINE Polacrilex
GUM USP, 
4 mg (nicotine)

STOP SMOKING AID

Nicotine Polacrilex, 4 mg
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 Nicotine Polacrilex Gum USP, 2 mg

4 mg        
Original

110 pieces (4 mg Each)

Nicotine Polacrilex, Original

Nicotine Polacrilex, Original

Nicotine Polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-196
Route of Administration BUCCAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
BUTYLATED HYDROXYTOLUENE
carnauba wax
SODIUM BICARBONATE
SODIUM CARBONATE
sorbitol
talc

Product Characteristics

Color Size Shape
WHITE (off-white to tan) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:63868-196-11 11 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074507 1999-10-01


Nicotine Polacrilex, Original

Nicotine Polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-195
Route of Administration BUCCAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
BUTYLATED HYDROXYTOLUENE
carnauba wax
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
SODIUM BICARBONATE
SODIUM CARBONATE
sorbitol
talc

Product Characteristics

Color Size Shape
YELLOW (yellowish) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:63868-195-11 11 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074707 1999-10-01


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Be sure to consult your doctor before taking any medication!
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