NICOTINE- nicotine polacrilex gum, chewing 
The Kroger Co.

----------

Drug Facts

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 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

  • a sodium-restricted diet
  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
  • stomach ulcer or diabetes
  • history of seizures

Ask a doctor or pharmacist before use if you are

  • using a non-nicotine stop smoking drug
  • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

  • mouth, teeth, or jaw problems occur
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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

acesulfame potassium, butylated hydroxytoluene, carnauba wax, D&C yellow #10 lake, FD&C blue #2 lake, FD&C red #40, FD&C Yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol, talc

Questions or comments?

Call 1-800-632-6900

Principal Display Panel

*Compare to the active ingredient in Nicorette® Gum

Uncoated

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (nicotine)

STOP SMOKING AID

Includes User's Guide

Uncoated Original Gum

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 (nicotine)

Sugar-free

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.

To remove the gum, tear off single unit.

Peel off backing starting at corner with loose edge.

Push gum through foil

*This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette Gum.

See inside for more details or visit www.nitthehabit.com

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

DISTRIBUTED BY THE KROGER CO.,

CINCINNATI, OHIO 45202

Package Label

Nicotine polacrilex (equal to4 mg nicotine)

KROGER Uncoated Nicotine Gum Original Flavor

NICOTINE 
nicotine polacrilex gum, chewing
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-671
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
SORBITOL (UNII: 506T60A25R)  
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)  
Product Characteristics
Color yellow (yellowish) Score no score
Shape SQUARE Size 14mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-671-11 110 in 1 CARTON 06/03/2022
1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074707 06/03/2022
Labeler - The Kroger Co. (006999528)

Revised: 2/2025
Document Id: 5816a557-6762-4172-baba-e08913384fac
Set id: f801e8b2-b789-41f4-b35e-ea3a82d2bb9c
Version: 3
Effective Time: 20250225
 
The Kroger Co.