NICOTINE- nicotine polacrilex gum, chewing 
Sam's West, Inc.

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Nicotine Gum Original Flavor

Active Ingredient (in each chewing piece)

Nicotine Polacrilex.....2 mg (nicotine)

Nicotine Polacrilex.....4 mg (nicotine)

Purpose

Stop smoking aid

Use

Warnings

Pregnancy/Breastfeeding

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

  • a sodium-restricted diet
  • heart disease, recent heart attack, or irregular heartbeat.  Nicotine can increase your heart rate.
  • high blood pressure not controlled with medication.  Nicotine can increase blood pressure.
  • stomach ulcer or diabetes
  • history of seizures

Ask a doctor or pharmacist before use if you are

  • using a non-nicotine stop smoking drug
  • taking prescription medicine for depression or asthma.  Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

  • mouth, teeth, or jaw problems occur
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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 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

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

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.

Questions

Questions or comments? Call 1-877-440-7867

Additional Information Found on Packaging

 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.

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.

Distributed by:

Sam's West, Inc.

Bentonville, AR 72716

DP22504
DP22755


Principal Display Panel

Compare to Nicorette® Gum 

active ingredient*

NDC 68196-010-02

Member's Mark

2 mg

Original Flavor

Sugar Free

Nicotine Gum

Nicotine Polacrilex Gum USP, (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

actual size
Original Flavor

396
Pieces

*Nicorette® is a registered trademark of GlaxoSmithKline Consumer Healthcare, L.P.
This product is not affiliated with GlaxoSmithKline Consumer Healthcare, L.P.

DP22504

Nicotine Polacrilex Gum USP 2 mg Original DP22504

Nicotine Polacrilex Gum USP 2 mg Original DP22504

Principal Display Panel

Compare to Nicorette® Gum 

active ingredient*

NDC 68196-011-02

Member's Mark

4 mg

Original Flavor

Sugar Free

Nicotine Gum

Nicotine Polacrilex Gum USP, (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

actual size
Original Flavor

396
Pieces

*Nicorette® is a registered trademark of GlaxoSmithKline Consumer Healthcare, L.P.
This product is not affiliated with GlaxoSmithKline Consumer Healthcare, L.P.

DP22755

Nicotine Polacrilex Gum USP 4 mg Original Flavor

Nicotine Polacrilex Gum USP 4 mg Original Flavor

Principal Display Panel

DP23483

DP23483_Nicotine Gum User Guide_231566-01_R0518_page1

DP23483_Nicotine Gum User Guide_231566-01_R0518_page1

Principal Display Panel

DP23483

DP23483_Nicotine Gum User Guide_231566-01_R0518_page2

DP23483_Nicotine Gum User Guide_231566-01_R0518_page2

Principal Display Panel

DP23483

DP23483_Nicotine Gum User Guide_231566-01_R0518_page3

DP23483_Nicotine Gum User Guide_231566-01_R0518_page3

NICOTINE 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-010
Route of AdministrationORAL
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)  
POLACRILIN (UNII: RCZ785HI7S)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorwhite (off-white to tan) Scoreno score
ShapeSQUARE (biconvex) Size14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-010-02396 in 1 CARTON10/16/2017
133 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07450710/16/201706/30/2021
NICOTINE 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-011
Route of AdministrationORAL
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)  
POLACRILIN (UNII: RCZ785HI7S)  
Product Characteristics
ColoryellowScoreno score
ShapeSQUARE (biconvex) Size14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-011-02396 in 1 CARTON10/16/2017
133 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07470710/16/2017
Labeler - Sam's West, Inc. (051957769)

Revised: 7/2021
Document Id: c2755198-b18d-4e80-8326-25d6dfba7c67
Set id: 809f691e-8886-4e59-bcd9-0d0dcc435375
Version: 7
Effective Time: 20210713
 
Sam's West, Inc.