Nicotine Polacrilex Gum, Chewing
FDA Label NDC 50090-8146
11 label sections · Submitted to the FDA by A-s Medication Solutions · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Nicotine Polacrilex (NDC 50090-8146). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each chewing piece), purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Chewing Piece)
Nicotine Polacrilex 4 mg (nicotine)
Purpose
Stop smoking aid
Use
reduces withdrawal symptoms, including nicotine craving, associated with quitting 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.
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 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, 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)
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:
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.
| 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 |
Other Information
each piece contains: calcium 120 mg, sodium 8 mg
store at 20 -25°C (68 -77°F)
protect from light
Questions Or Comments?
Call 1-844-474-7464
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Revised: 07/2024
* Please review the disclaimer below.
