NICOTINE POLACRILEX COATED MINT- nicotine polacrilex gum, chewing 
Roman Health Ventures Inc.

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Nicotine Polarilex Coated Mint 2 mg and 4 mg - Roman

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

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

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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

Weeks 1 to 6Weeks 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

Directions - 4 mg

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

Other information - 2 mg

Other information - 4 mg

Inactive ingredients - 2 mg

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Inactive ingredients - 4 mg

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 aluminum lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-877-440-7867

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.


    Instructions

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


FREE AUDIO CD
Upon Request.
See Inside.

 

 

 

Principal Display Panel - 2 mg

ZERO

Compare to the active ingredient in Nicorette ® Fresh Mint TM Coated Gum*

Sugar Free

Nicotine Polacrilex
Gum USP, 2 mg (nicotine)

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

Coated Mint

160 Pieces, 2 mg Each

2 mg coated mint 160

Principal Display Panel - 4 mg

ZERO

Compare to the active ingredient in Nicorette ® Fresh Mint TM Coated Gum*

Sugar Free

Nicotine Polacrilex
Gum USP, 4 mg (nicotine)

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 Nicotine Polacrilex Gum USP, 2 mg

Coated Mint

160 Pieces, 4 mg Each

4 mg coated mint 160

NICOTINE POLACRILEX  COATED MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72484-428
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72484-428-16160 in 1 CARTON10/08/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869910/08/2018
NICOTINE POLACRILEX  COATED MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72484-429
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColoryellowScoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72484-429-16160 in 1 CARTON10/08/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869710/08/2018
Labeler - Roman Health Ventures Inc. (081317350)

Revised: 10/2019
Document Id: 956fb87b-f80a-6372-e053-2a95a90ac9ae
Set id: d60f90a5-10ea-442b-9ec5-2f2a69ec6441
Version: 2
Effective Time: 20191021
 
Roman Health Ventures Inc.