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Nicotine Polacrilex by Rugby Laboratories

Dosage form: gum, chewing
Ingredients: NICOTINE 2mg
Labeler: Rugby Laboratories
NDC Code: 0536-3404

Nicotine Polacrilex Gum 2 mg and 4 mg Coated Cinnamon - Rugby

Drug Facts

Active ingredient (in each chewing piece) - 2 mg

Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg

Nicotine Polacrilex 4 mg (nicotine)

Purpose

Stop smoking aid

Use
  • 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 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.

Directions - 2 mg
  • 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. 

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

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

Inactive ingredients - 2 mg

acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Inactive ingredients - 4 mg

acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

TO INCREASE YOUR SUCCESS IN QUITTING:

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

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

PRINCIPAL DISPLAY PANEL - 2 mg

Rugby®                                           COMPARE TO THE ACTIVE INGREDIENT
NDC 0536-3404-01                        IN NICORETTE®CINNAMON SURGE™ COATED GUM*

SUGAR FREE
NICOTINE Polacrilex GUM
USP, 2 mg (nicotine)

2 mg   COATED CINNAMON

STOP SMOKING AID

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

100 chewing pieces





 

PRINCIPAL DISPLAY PANEL - 4 mg

Rugby®                                         COMPARE TO THE ACTIVE INGREDIENT
NDC 0536-3405-01                       IN NICORETTE® CINNAMON SURGE™ COATED GUM*

SUGAR FREE
NICOTINE Polacrilex GUM
USP, 4 mg (nicotine)

4 mg  COATED CIINNAMON

STOP SMOKING AID
FREE AUDIO CD  Upon Request. See Inside.

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

100 chewing pieces



NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3404
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
ACESULFAME POTASSIUM 
BUTYLATED HYDROXYTOLUENE 
CARNAUBA WAX 
FD&C RED NO. 40 
HYDROXYPROPYL CELLULOSE (120000 MW) 
HYPROMELLOSE, UNSPECIFIED 
SODIUM BICARBONATE 
SODIUM CARBONATE 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
XYLITOL 
Product Characteristics
ColorPINK (light pink) Scoreno score
ShapeSQUARESize14mm
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3404-3740 BLISTER PACK in 1 CARTON
11 GUM, CHEWING in 1 BLISTER PACK
2NDC:0536-3404-01100 BLISTER PACK in 1 CARTON
21 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921607/08/2009
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3405
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
ACESULFAME POTASSIUM 
BUTYLATED HYDROXYTOLUENE 
CARNAUBA WAX 
FD&C RED NO. 40 
HYDROXYPROPYL CELLULOSE (120000 MW) 
HYPROMELLOSE, UNSPECIFIED 
SODIUM BICARBONATE 
SODIUM CARBONATE 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
XYLITOL 
Product Characteristics
ColorPINK (dark pink) Scoreno score
ShapeSQUARESize14mm
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3405-3740 BLISTER PACK in 1 CARTON
11 GUM, CHEWING in 1 BLISTER PACK
2NDC:0536-3405-01100 BLISTER PACK in 1 CARTON
21 GUM, CHEWING in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921907/08/2009
Labeler - Rugby Laboratories (079246066)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 01/2018
 
Rugby Laboratories

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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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