NICOTINE- nicotine polacrilex gum, chewing 
QUALITY CHOICE (Chain Drug Marketing Association)

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Nicotine Polacrilex Coated Ice Mint 2 mg and 4 mg - Leader

Drug Facts

Active ingredient (in each chewing piece)

Nicotine polacrilex 2 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

Other information - 2 mg

Inactive ingredients - 2 mg

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel - 2 mg

*Compare to the active ingredient of Nicorette® Gum

Nicotine Gum

Stop Smoking Aid

Nicotine polacrilex gum USP, 2 mg (nicotine)

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, 4 mg

Sugar free

COATED ICE MINT FLAVOR

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.

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

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

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com


Package label

Nicotine Polacrilex 2 mg (nicotine)

QUALITY CHOICE Nicotine Gum Coated Ice Mint Flavor

NICOTINE 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-845
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)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-845-2020 in 1 CARTON12/31/202012/31/2025
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20479412/31/202012/31/2025
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 10/2023
Document Id: 2f71dfc0-c459-4486-93e8-a86e22e920c5
Set id: 69f41191-eb3a-4005-9bd0-72885fa94c54
Version: 4
Effective Time: 20231017
 
QUALITY CHOICE (Chain Drug Marketing Association)