MedPath

Nicotine

Drug Facts

Approved
Approval ID

63fce25d-457f-4048-86a4-1805f603936c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

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 Code69842-957
Application NumberANDA209206
Product Classification
M
Marketing Category
C73584
G
Generic Name
nicotine polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (12)

NICOTINEActive
Quantity: 2 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

Package Label

![Nicotine Polacrilex USP, 2 mg](/dailymed/image.cfm?name=nicotine-2-mg-sugar- free-mint-maxi-lozenge-rub-del-1.jpg&id=894970)

CVS HEALTYH Sugar Free Nicotine Lozenge Mint Maxi

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/26/2025

Use

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/26/2025

Active ingredient (in each lozenge)

Nicotine polacrilex USP, 2 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/26/2025

Purpose

Stop smoking aid

WARNINGS SECTION

LOINC: 34071-1Updated: 8/26/2025

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.

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 problems occur
  • persistent indigestion or severe sore throat occurs
  • 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.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it 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: 8/26/2025

Directions

*if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.

  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the lozenge on your quit day *if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge ***if you smoke your first cigarette within 30 minutes of waking up,**use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

*nicotine lozenge is a medicine and must be used a certain way to get the best results

  • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 to 30 minutes). Minimize swallowing.Do not chew or swallow lozenge.
  • you may feel a warm or tingling sensation
  • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 to 30 minutes)
  • do not eat or drink 15 minutes before using or while the lozenge is in your mouth
  • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
  • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects *do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
  • It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/26/2025

Other information

*each lozenge contains: sodium 14 mg

  • store at 20º-25ºC (68º-77ºF)
  • keep bottle tightly closed and protect from light

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate, sodium carbonate, sucralose,xanthan gum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/26/2025

Questions or comments?

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Nicotine - FDA Drug Approval Details