NICOTINE POLACRILEX, ORIGINAL- nicotine polacrilex gum, chewing 
Chain Drug Consortium, LLC

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Nicotine Polacrilex Gum 2 mg and 4 mg Original Flavor - Premier Value (Chain Drug Consortium, LLC)

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

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel 2 mg

COMPARE TO THE ACTIVE INGREDIENT IN NICORETTE® GUM*

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, 4mg

ORIGINAL 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 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:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Package label 2 mg 286

Nicotine Polacrilex 2 mg (nicotine)

PREMIER VALUE Nicotine Gum Original Flavor

Package label 282

Nicotine Polacrilex 2 mg (nicotine)

PREMIER VALUE nicotine Gum Original Flavor

Principal display panel 4 mg

COMPARE TO THE ACTIVE INGREDIENT IN NICORETTE® GUM*

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 MOREW THAN 30 MINUTES after waking up, use Nicotine Polacrilex Gum USP, 2 mg

ORIGINAL 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 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.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Package label 4 mg 287

Nicotine Polacrilex 4 mg (nicotine)

PREMIER VALUE Nicotine Gun Original Flavor

Package label 4 mg 283

Nicotine Polacrilex 4 mg (nicotine)

PREMIER VALUE Nicotine Gum Original Flavor

NICOTINE POLACRILEX, ORIGINAL 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-282
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:68016-282-505 in 1 CARTON09/01/201309/30/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07450709/01/201309/30/2018
NICOTINE POLACRILEX, ORIGINAL 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-286
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:68016-286-6211 in 1 CARTON07/01/2013
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07450707/01/2013
NICOTINE POLACRILEX, ORIGINAL 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-283
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:68016-283-505 in 1 CARTON07/01/201310/31/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07470707/01/201310/31/2018
NICOTINE POLACRILEX, ORIGINAL 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-287
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:68016-287-6211 in 1 CARTON06/01/2013
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07470706/01/2013
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 11/2022
Document Id: 9ecc9d1a-6ab6-4484-a9f3-31860d36b28e
Set id: cb67cd5e-9264-4530-a678-da299476f356
Version: 11
Effective Time: 20221121
 
Chain Drug Consortium, LLC