NICOTINE POLACRILEX COATED FRUIT- nicotine polacrilex gum, chewing 
Cardinal Health (Leader) 70000

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Nicotine Polacrilex Coated Fruit 2 mg and 4 mg - Leader

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, 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, xylitol.

Question or comments?

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

Principal display panel 2 mg

COMPARE TO NICORETTE® FRUIT CHILL® GUM active ingredient

Sugar-Free

Nicotine Gum

Nicotine Polacrilex Gum USP, 2 mg (nicotine)

Stop Smoking Aid

2 mg

Coated Fruit Flavor

ForThose 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 weweks.

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® Fruit Chill® Gum.

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

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package label 2 mg

Nicotine Polacrilex 2 mg (nicotine)

LEADER Sugar Free Nicotine Gum Fruit Flavor

Principal display panel 4 mg

COMPARE TO NICORETTE® FRUIT CHILL® GUM active ingredient*

Sugar-Free

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (Nicotine)

Stop Smoking Aid

4 mg Coated Fruit Flavor

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 Lone Enough - Use Nicotine Polacrilex 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® Fruit Chill® Gum.

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

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package label 4 mg

Nicotine Polacrilex 4 mg (nicotine)

LEADER Sugar Free Nicotine Gum Fruit Flavor

NICOTINE POLACRILEX  COATED FRUIT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0346
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:70000-0346-120 in 1 CARTON07/03/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07904407/03/2018
NICOTINE POLACRILEX  COATED FRUIT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0342
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)  
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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
Colorbrown (light tan) Scoreno score
ShapeSQUARESize14mm
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0342-120 in 1 CARTON07/03/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07903807/03/2018
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 6/2022
Document Id: 858e3dac-68bd-46dc-a8df-9fee1ad46489
Set id: d6c7a2ab-109d-40df-bce0-30c3531eb982
Version: 14
Effective Time: 20220621
 
Cardinal Health (Leader) 70000