Nicotine Mini 2 mg/1

nicotine polacrilex · LOZENGE · HC Jones, Inc.

No Recall History

Plain English

Nicotine Mini is a lozenge containing nicotine polacrilex at 2 mg/1, taken oral. Manufactured by HC Jones, Inc..

Key Facts

Brand Name: Nicotine Mini
Generic Name: nicotine polacrilex
NDC Code (Product): 83253-262
Manufacturer: HC Jones, Inc.
Strength: 2 mg/1
Dosage Form: LOZENGE
Route: ORAL
Marketing Status
Application #: ANDA207868
Drug Class: Cholinergic Nicotinic Agonist [EPC]
Marketing Start: 04/30/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective2,546 reports

nausea1,576 reports

nicotine dependence1,313 reports

headache843 reports

overdose821 reports

macular degeneration787 reports

malaise751 reports

foetal exposure during pregnancy741 reports

product adhesion issue728 reports

dizziness711 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. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 w…

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 • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. • high blood pressure not controlled with medication. Nicotine can increase your 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 problems occur • persistent indigestion or severe sore throat occurs • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat • you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of chil…

Frequently Asked Questions

What is Nicotine Mini used for?

Nicotine Mini contains nicotine polacrilex. It is a lozenge taken oral. Consult your doctor for specific uses.

Is Nicotine Mini a controlled substance?

Nicotine Mini is not classified as a controlled substance by the DEA.

What is the generic name for Nicotine Mini?

The generic name for Nicotine Mini is nicotine polacrilex. There are 12 other brand versions of nicotine polacrilex.

What is the NDC code for Nicotine Mini 2 mg/1?

The NDC (National Drug Code) for Nicotine Mini 2 mg/1 is 83253-262, listed by HC Jones, Inc..

Product NDC

83253-262

Package NDC

83253-262-27

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)