Drugplain

members mark nicotine 2 mg/1

Nicotine Polacrilex · LOZENGE · Sam's West Inc

No Recall History
Plain English

members mark nicotine is a lozenge containing nicotine polacrilex at 2 mg/1, taken oral. Manufactured by Sam's West Inc.

Key Facts

Brand Name
members mark nicotine
Generic Name
Nicotine Polacrilex
NDC Code (Product)
68196-082
Manufacturer
Sam's West Inc
Strength
2 mg/1
Dosage Form
LOZENGE
Route
ORAL
Marketing Status
Application #
ANDA077007
Drug Class
Cholinergic Nicotinic Agonist [EPC]
Marketing Start
07/29/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,400 reports
nausea700 reports
nicotine dependence611 reports
macular degeneration564 reports
wrong technique in product usage process424 reports
oral discomfort330 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 Nicotine Polacrilex Gum, 2 mg • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg 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

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. 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) Keep out of reach of children and pets. P

Frequently Asked Questions

What is members mark nicotine used for?

members mark nicotine contains Nicotine Polacrilex. It is a lozenge taken oral. Consult your doctor for specific uses.

Is members mark nicotine a controlled substance?

members mark nicotine is not classified as a controlled substance by the DEA.

What is the generic name for members mark nicotine?

The generic name for members mark nicotine is Nicotine Polacrilex. There are 12 other brand versions of Nicotine Polacrilex.

What is the NDC code for members mark nicotine 2 mg/1?

The NDC (National Drug Code) for members mark nicotine 2 mg/1 is 68196-082, listed by Sam's West Inc.