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Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint

nicotine polacrilex · Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint is a cholinergic nicotinic agonist (over-the-counter) containing nicotine polacrilex, made by Dr. Reddy's Laboratories Inc..

Type
Over the counter
Drug class
Cholinergic Nicotinic Agonist
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
nicotine polacrilex
Active ingredients
Nicotine
Drug class
Cholinergic Nicotinic Agonist
Dosage forms
Gum, chewing
Label holder
Dr. Reddy's Laboratories Inc.
FDA application
ANDA078697
Label updated
12/23/2025

Active ingredients

(in each chewing piece) Nicotine Polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Uses

Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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.

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

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

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

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.

Inactive ingredients

Acacia, acesulfame potassium, carnauba wax, D&C yellow #10 aluminum lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide, xylitol.

Questions?

Call toll-free 1-800-585-8682 weekdays (8:00 am - 8:00 pm EST

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Gum, chewing4 mgoral1

Manufacturers and labels

1 FDA label

  • Dr. Reddy's Laboratories Inc.Shown hereANDA078697 · Label 12/23/2025 · NDC 75907-303Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint: common questions

What is Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint used for?
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Is Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint a prescription drug?
No. Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint?
Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
Who makes Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint?
Dr. Reddy's Laboratories Inc. lists Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/23/2025 · Label text is shown as published by the manufacturer. Not medical advice