Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 4 mg/1

Nicotine Polacrilex · GUM, CHEWING · Dr. Reddy's Laboratories Inc.

No Recall History

Plain English

Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint is a gum, chewing containing nicotine polacrilex at 4 mg/1, taken oral. Manufactured by Dr. Reddy's Laboratories Inc..

Key Facts

Brand Name: Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint
Generic Name: Nicotine Polacrilex
NDC Code (Product): 75907-303
Manufacturer: Dr. Reddy's Laboratories Inc.
Strength: 4 mg/1
Dosage Form: GUM, CHEWING
Route: ORAL
Marketing Status
Application #: ANDA078697
Drug Class: Cholinergic Nicotinic Agonist [EPC]
Marketing Start: 06/12/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,396 reports

nausea699 reports

nicotine dependence608 reports

macular degeneration564 reports

wrong technique in product usage process419 reports

oral discomfort329 reports

dyspepsia314 reports

intentional drug misuse291 reports

malaise287 reports

headache240 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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 anot…

Warnings

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.

Frequently Asked Questions

What is Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint used for?

Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint contains Nicotine Polacrilex. It is a gum, chewing taken oral. Consult your doctor for specific uses.

Is Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint a controlled substance?

Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint is not classified as a controlled substance by the DEA.

What is the generic name for Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint?

The generic name for Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint is Nicotine Polacrilex. There are 11 other brand versions of Nicotine Polacrilex.

What is the NDC code for Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 4 mg/1?

The NDC (National Drug Code) for Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 4 mg/1 is 75907-303, listed by Dr. Reddy's Laboratories Inc..

Product NDC

75907-303

Package NDC

75907-303-10

Other Nicotine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)