Nicorette Spearmint Burst 4 mg/1

nicotine polacrilex · GUM, CHEWING · Haleon US Holdings LLC

No Recall History

Plain English

Nicorette Spearmint Burst is a gum, chewing containing nicotine polacrilex at 4 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name: Nicorette Spearmint Burst
Generic Name: nicotine polacrilex
NDC Code (Product): 0135-0533
Manufacturer: Haleon US Holdings LLC
Strength: 4 mg/1
Dosage Form: GUM, CHEWING
Route: ORAL
Marketing Status
Application #: NDA020066
Drug Class: Cholinergic Nicotinic Agonist [EPC]
Marketing Start: 09/13/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective3,343 reports

nicotine dependence2,993 reports

intentional drug misuse2,815 reports

nausea1,651 reports

drug administration error1,007 reports

malaise849 reports

oral discomfort628 reports

wrong technique in product usage process614 reports

dizziness587 reports

dyspepsia574 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 (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 aft…

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 a pharmacist before use if you are using a non-nicotine stop smoking drug taking a 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 (For Cinnamon Surge) oral blistering occurs you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reac…

Frequently Asked Questions

What is Nicorette Spearmint Burst used for?

Nicorette Spearmint Burst contains nicotine polacrilex. It is a gum, chewing taken oral. Consult your doctor for specific uses.

Is Nicorette Spearmint Burst a controlled substance?

Nicorette Spearmint Burst is not classified as a controlled substance by the DEA.

What is the generic name for Nicorette Spearmint Burst?

The generic name for Nicorette Spearmint Burst is nicotine polacrilex. There are 12 other brand versions of nicotine polacrilex.

What is the NDC code for Nicorette Spearmint Burst 4 mg/1?

The NDC (National Drug Code) for Nicorette Spearmint Burst 4 mg/1 is 0135-0533, listed by Haleon US Holdings LLC.

Product NDC

0135-0533

Package NDC

0135-0533-02

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)