Nicotine Polacrilex

Manufacturer
P & L Development, LLC
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:48:31

Label at a glance#

ProductNicotine Polacrilex
Active ingredientNICOTINE
Label structure14 sections

Dosage and administration

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 within 30 minutes of waking up, use 4 mg nicotine gum if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following...

Label contents#

Full prescribing information#

Active ingredient (in each chewing piece)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex  2 mg (nicotine)

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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 within 30 minutes of waking up, use 4 mg nicotine gum
  • if you smoke your first cigarette more than 30 minutes after waking up, use 2 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

Other information - 2 mg

SPL UNCLASSIFIED SECTION

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

Inactive ingredients - 2 mg

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Nicorette® Gum††

Nicotine Gum

NICOTINE POLACRILEX GUM USP, 2 mg (NICOTINE)

STOP SMOKING AID

Sugar Free

Coated Mint Flavor

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 USP, 4 mg

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 owner of the registered trademark Nicorette®.

Manufactured By:

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Gum Sugar Coated Mint Flavor
Nicotine Gum Sugar Coated Mint Flavor

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-428NICOTINE POLACRILEX GUM, CHEWING [P & L DEVELOPMENT, LLC]1Unmatched20241130_f3175d35-bfd1-4a75-b897-6916695ce6f9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-42859726-428-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
71de3d5f-e3cf-40a4-9424-7c577ae5cbe5f3175d35-bfd1-4a75-b897-6916695ce6f92026-01-08WarningsExact identifier
spl set id: f3175d35-bfd1-4a75-b897-6916695ce6f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.