MedPath

Nicotine

Nicotine 4 mg Fruit Coated USP Gum

Approved
Approval ID

fbb3f6af-529f-40d8-a193-1aed4f2aa769

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

P & L Development, LLC

DUNS: 800014821

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Nicotine Polacrilex

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59726-913
Application NumberANDA079038
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (16)

NICOTINEActive
Quantity: 4 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/9/2025

Package Label

![Nicotine Polacrilex (equal to 4 mg nicotine)](/dailymed/image.cfm?name=nicotine-4-mg-fruit-coated-usp- gum-1.jpg&id=897088)

WELLNESS BASICS Sugar Free Nicotine Polacrilex Coated Fruit Flavor

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/9/2025

Use

  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/9/2025

Other information

  • each piece contains: calcium 115 mg, sodium 8 mg
  • store at 20 - 25ºC (68 - 77ºF)
  • protect from light

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/9/2025

Active ingredient (in each chewing piece)

Nicotine Polacrilex (equal to 4 mg nicotine)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/9/2025

Purpose

Stop smoking aid

WARNINGS SECTION

LOINC: 34071-1Updated: 9/9/2025

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.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/9/2025

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 blood pressure.
  • stomach ulcer or diabetes
  • history of seizures

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 9/9/2025

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/9/2025

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)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/9/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/9/2025

Directions

*if you are under 18 years of age, ask a doctor before use

  • before using this product, read the enclosed User's Guide for complete directions and other important information

  • begin using the gum on your quit day

*if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum

*if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:

** 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

  • nicotine gum is a medicine and must be used a certain way to get the best results

  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.

  • repeat this process until most of the tingle is gone (about 30 minutes)

  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.

  • do not use more than 24 pieces a day

  • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/9/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/9/2025

Questions or comments?

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Nicotine - FDA Drug Approval Details