NICOTINE POLACRILEX- nicotine polacrilex gum, chewing 
Rising Pharma Holdings, Inc.

----------

Nicotine Polacrilex Gum USP, Coated Mint Flavor 2 mg

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

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

Questions or comments?

Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Principal Display Panel (2 mg Gum)

Compare to the active ingredient in Nicorrette® Gum

Nicotine Gum

Stop Smoking Aid

NICOTINE POLACRILEX GUM USP, 2 MG (NICOTINE)

2 mg

Coated Mint 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 GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Gum.

Package Label (2 mg Gum)

nicotine-gum-2mg-part1

nicotine-gum-2mg-part2

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-322
Route of AdministrationORAL
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:57237-322-0110 in 1 CARTON08/10/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869908/10/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 8/2023
Document Id: af30fe4f-c148-4987-822f-18bbd0ef0161
Set id: a3f19365-d0d1-43ad-be15-48dc4320e361
Version: 1
Effective Time: 20230823
 
Rising Pharma Holdings, Inc.