NICOTINE POLACRILEX COATED FRUIT- nicotine polacrilex gum, chewing 
Publix Supermarkets, Inc.

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Nicotine Polacrilex Gum 2 mg and 4 mg Coated Fruit - Publix

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(1-800-222-1222) 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

Other information - 4 mg

Inactive ingredients  - 2 mg

acacia, acesulfame potassium, carnauba wax, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Inactive ingredients - 4 mg

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 lake, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Principal display panel 2 mg

*Compare to the active ingredient in Nicorette® Gum

SUGAR FREE

nicotine gum

NICOTINE POLACRILEX GUM USP, 2mg (nicotine)

STOP SMOKING AID

COATED FRUIT FLAVOR

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, 4 mg

2 mg

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 for the full 12 weeks.

4. Use with a Support Program as directed in the enclosed User's Guide.

Blister packages for your protect. Do not use if individual seals are open or torn.

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Gum.

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY,

LAKELAND,FL 33811, 1-888-267-3037

Package label 2 mg

Nicotine Polacrilex 2 mg (nicotine)

PUBLIX Sugar Free Nicotine Coated Fruit Flavor

Principal display panel 4 mg

*Compare to the active ingredient in Nicorette® Gum

SUGAR FREE

nicotinegum

NICOTINE POLACRILEX GUM USP, 4 mg (NICOTINE

STOP SMOKING AID

COATED FRUIT FLAVOR

FOR THOSE SMOKE THEIR FIRST CIGARETTE WITHIN 302 MINUTES OG WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up use Nicotine Polacrilex Gum USP, 2 mg

4 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivates 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.

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

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., Distributor of Nicorette® Gum

DISTRIBUTED BY PUBLIX SUPERMARKETS, INC.,

3300 PUBLIX CORPARATE PARKWAY,

LAKELAND, FL 33811, 1-888-267-3037

Package label 4 mg

Nicotine Polacrilex 4 mg (nicotine)

PUBLIX Nicotine Gum Fruit Flavor

NICOTINE POLACRILEX  COATED FRUIT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-503
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)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorbrown (light brown) Scoreno score
ShapeSQUARESize14mm
FlavorFRUIT (coated fruit) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-503-4410 in 1 CARTON01/01/2014
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07904401/01/2014
NICOTINE POLACRILEX  COATED FRUIT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-504
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)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorbrown (light tan) Scoreno score
ShapeSQUARESize14mm
FlavorFRUIT (coated fruit) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-504-4410 in 1 CARTON01/01/2014
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07903801/01/2014
Labeler - Publix Supermarkets, Inc. (006922009)

Revised: 8/2022
Document Id: a8eef673-113c-4ea4-80da-e27d388b4314
Set id: c161e2d6-7691-4fd0-9f91-acfc33685420
Version: 10
Effective Time: 20220824
 
Publix Supermarkets, Inc.