NICOTINE POLACRILEX ORIGINAL FLAVOR- nicotine polacrilex gum, chewing 
NICOTINE POLACRILEX ORIGIANL FLAVOR- nicotine polacrilex gum, chewing 
Publix Supermarkets, Inc.

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Nicotine Polacrilex Gum 2 mg and 4 mg Original Flavor - 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 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

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

Inactive ingredients - 4 mg

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.

Principal display panel 2 mg

*Compare to the active ingredient in Nicorette® Gum

SUGAR FREE

nicotinegum

NICOTINE POLACRILEX GUM USP, 2 mg (nicotine)

STOP SMOKING AID

ORIGINAL 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 USP, 4 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 da 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.

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

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

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 Nicotine Polacrilex Gum Original Flavor

Principal display panel 4 mg

*Compare to the active ingredient in Nicorette® Gum

SUGAR FREE

nicotine gum

NICOTINE POLACRILEX GUM USP, 4 mg (nicotine)

STOP SMOKING AID

ORIGINAL FLAVOR

FOR YHOSE WHO SMOKE THEIR FIRST CIGARETTE WITH 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

TO INCREASE YOUR SUCCES 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.

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

DISTRIBUTED BY PUBLIX SUPERMARKETS. INC.,

3300 PUBLIX CORPORATE PARKWAY,

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

Package label 4 mg

Nicotine Polacrilex 4 mg (nicotine)

PUBLIX Nicotine Polacrilex GUM Original Flavor

NICOTINE POLACRILEX  ORIGINAL FLAVOR
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-608
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorwhite (off-white to tan) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-608-6211 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
ANDAANDA07450701/01/2014
NICOTINE POLACRILEX  ORIGIANL FLAVOR
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-609
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
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)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Coloryellow (yellowish) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-609-6211 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
ANDAANDA07470701/01/2014
Labeler - Publix Supermarkets, Inc. (006922009)

Revised: 12/2022
Document Id: c3f157ee-d166-4097-b85d-a59cb3185eee
Set id: 540c88bd-70dc-416a-8d8e-0a33b2b29563
Version: 12
Effective Time: 20221213
 
Publix Supermarkets, Inc.