NICOTINE POLACRILEX COATED FRUIT- nicotine polacrilex gum, chewing 
CVS Pharmacy

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Nicotine Polacrilex Coated Fruit 2 mg and 4 mg - CVS

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

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.

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*

Sugar Free

Nicotine 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, 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 IN INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Package label 2 mg

Nicotine Polacrilex 2 mg (nicotine)

CVS HEALTH Sugar Free Nicotine Gum Coated Fruit 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

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

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 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:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Package label 4 mg

Nicotine Polacrilex 4 mg (nicotine)

CVS HEALTH Sugar Free Nicotine Gum Coated Fruit Flavor

NICOTINE POLACRILEX  COATED FRUIT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-024
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
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-024-44100 in 1 CARTON01/01/2014
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69842-024-7910 in 1 CARTON01/01/2014
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:69842-024-1520 in 1 CARTON01/01/2014
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:69842-024-16160 in 1 CARTON01/01/2014
41 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:69842-025
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
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-025-16160 in 1 CARTON01/01/2014
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69842-025-44100 in 1 CARTON01/01/2014
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:69842-025-7910 in 1 CARTON01/01/2014
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:69842-025-1520 in 1 CARTON01/01/2014
41 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 - CVS Pharmacy (062312574)

Revised: 2/2022
Document Id: 5a2b44c9-eb69-4c5d-9ade-f2783c4c3d7e
Set id: 8c5e99d7-9d2d-488b-a804-496edafd30cf
Version: 10
Effective Time: 20220210
 
CVS Pharmacy