NICOTINE GUM

NICOTINE POLACRILEX ORAL HUMAN OTC DRUG

NICOTINE GUM is an FDA drug label for the active ingredient NICOTINE POLACRILEX manufactured by Guangzhou Shuimu Jiahe Trading Co., Ltd. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260806.

Generic name
NICOTINE POLACRILEX
Manufacturer
Guangzhou Shuimu Jiahe Trading Co., Ltd.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
87494-002
Application
M012
Label effective
20260806

About this product

NICOTINE GUM is an FDA-registered drug product whose active ingredient is NICOTINE POLACRILEX. It is labelled by Guangzhou Shuimu Jiahe Trading Co., Ltd. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 87494-002, application M012, label effective 20260806. 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.

What it is used for

Across FDA labelling, products containing NICOTINE POLACRILEX are most often described in connection with: first cigarette, nicotine polacrilex, weeks weeks, hours piece, tingle gone, years age, ask doctor, product read. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Nicotine (equal to 4 mg nicotine)

Indications & Usage

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 Nicotine Polacrilex Gum, 4 mg your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule: Weeks 1–6 Weeks 7–9 Weeks 10–12 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

Dosage & Administration

reduces withdrawal symptoms, including nicotine craving, associated withquitting smoking

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.

More products with the same ingredient

NICOTINE POLACRILEX

BLIP

Blip Products, Inc. View label

BLIP

Blip Products, Inc. View label

BLIP

Blip Products, Inc. View label

Basic Care Nicotine

Amazon.com Services LLC View label

Basic Care Nicotine

Amazon.com Services LLC View label

Basic Care Nicotine

Amazon.com Services LLC View label

Basic Care Nicotine

Amazon.com Services LLC View label

Berkley and Jensen NICOTINE

BJWC View label

How products containing NICOTINE POLACRILEX compare

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.

Dosage formProductsManufacturerProducts
— — Amazon.com Services LLC 26
— — Target Corporation 16
— — CVS Pharmacy 14
— — Publix Super Markets Inc 14
— — Strategic Sourcing Services LLC 14

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0004-2021 Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3. P & L Developments, LLC Class III Terminated 20201007

Frequently asked questions

What is NICOTINE GUM used for?
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 Nicotine Polacrilex Gum, 4 mg your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 …

Who makes NICOTINE GUM?
Guangzhou Shuimu Jiahe Trading Co., Ltd. is the labeler of record for NICOTINE GUM. 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 GUM come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is NICOTINE GUM 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 GUM been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.