Nicotine Polacrilex Coated Ice Mint

Nicotine Polacrilex Coated Ice Mint is an FDA-registered drug product whose active ingredient is NICOTINE POLACRILEX. It is labelled by CARDINAL HEALTH 110, LLC. DBA LEADER 70000 taken by buccal and marketed as a human otc drug product. Identifiers on file: NDC 70000-0344, application ANDA204833, label effective 20260413. It is one of 277 FDA drug label records sharing the active ingredient NICOTINE POLACRILEX. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing NICOTINE POLACRILEX are most often described in connection with: reduces withdrawal, symptoms including, nicotine craving, quitting smoking. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions - 2 mg 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.

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.

FDA lists 277 drug label records with NICOTINE POLACRILEX as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Nicotine Polacrilex Coated Ice Mint used for?
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Who makes Nicotine Polacrilex Coated Ice Mint?
CARDINAL HEALTH 110, LLC. DBA LEADER 70000 is the labeler of record for Nicotine Polacrilex Coated Ice Mint. 277 FDA label records share the active ingredient NICOTINE POLACRILEX, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Nicotine Polacrilex Coated Ice Mint come in?
administered by buccal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Nicotine Polacrilex Coated Ice Mint prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing NICOTINE POLACRILEX?
Yes. 277 FDA drug label records list NICOTINE POLACRILEX as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Nicotine Polacrilex Coated Ice Mint been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.