NICOTINE- nicotine polacrilex gum, chewing 
P & L Development, LLC

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Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate

Drug Facts

Active ingredient (in each chewing piece)

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

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

Inactive ingredients

acacia, acesulfame potassium, carnauba wax, D&C yellow #10, FD&C blue #2, FD&C red #40, FD&C yellow #6, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.

Questions or comments?

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

Principal Display Panel

*Compare to the active ingredient in Nicorette® Gum

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, 2 mg

4 mg

sugar-free

coated fruit flavor

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivate 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.

*This product is not manufactured or distributed by Haleon Group of Companies, distributor of Nicorette® Gum.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Package Label

Nicotine Polacrilex 4 mg (nicotine)

WELLNESS BASICS Nicotine Gum Coated Fruit Flavor

NICOTINE 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-913
Route of AdministrationORAL
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 RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colorbrown (light tan) Scoreno score
ShapeSQUARESize14mm
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-913-16160 in 1 CARTON03/01/2024
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07903803/01/2024
Labeler - P & L Development, LLC (800014821)

Revised: 3/2024
Document Id: f89d1920-87a7-4892-aef1-c832c76db40a
Set id: fbb3f6af-529f-40d8-a193-1aed4f2aa769
Version: 1
Effective Time: 20240301
 
P & L Development, LLC