NICOTINE POLACRILEX- nicotine polacrilex gum, chewing 
QUALITY CHOICE (Chain Drug Marketing Association)

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Nicotine Polacrilex Gum Coated Mint 2 mg ANDA078699 and 4 mg ANDA078697 - Quality Choice

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 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

Directions - 4 mg

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

Other information - 2 mg

• each piece contains: calcium 115 mg, sodium 8 mg

• store at 20 - 25ºC (68 - 77ºF) 

• protect from light

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

Instructions

To remove the gum, tear off single unit

Peel off backing starting at corner with loose edge.

Push gum through foil

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

 

Principal Display Panel - 2 mg

NDC 63868-168-20

QC
QUALITY CHOICE®

*Compare to the active ingredient in NICORETTE® Fresh MintTM

Sugar Free

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

Coated
Mint Flavor

20 PIECES (2 MG EACH)

2 mg coated mint



Principal Display Panel - 4 mg

NDC 63868-167-20

QC
QUALITY CHOICE®

*Compare to the active ingredient in NICORETTE® Fresh MintTM

Sugar Free

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

Coated
Mint Flavor

20 PIECES (4 MG EACH)

4 mg coated mint 20 count
 

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-168
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
FlavorMINT (coated mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-168-2020 in 1 CARTON07/01/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869907/01/201607/01/2025
NICOTINE POLACRILEX 
nicoitne polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-167
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
FlavorMINT (coated mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-167-2020 in 1 CARTON07/01/2016
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869707/01/201607/01/2025
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 5/2023
Document Id: 217f0271-e0e9-4cb0-a1d0-c5298788bd82
Set id: ed71a525-c738-4df1-b5d7-9352e17f9166
Version: 7
Effective Time: 20230508
 
QUALITY CHOICE (Chain Drug Marketing Association)