Mini Nicotine 4 mg/1

nicotine polacrilex · LOZENGE · P & L Development, LLC

No Recall History

Plain English

Mini Nicotine is a lozenge containing nicotine polacrilex at 4 mg/1, taken oral. Manufactured by P & L Development, LLC.

Key Facts

Brand Name: Mini Nicotine
Generic Name: nicotine polacrilex
NDC Code (Product): 59726-264
Manufacturer: P & L Development, LLC
Strength: 4 mg/1
Dosage Form: LOZENGE
Route: ORAL
Marketing Status
Application #: ANDA207868
Drug Class: Cholinergic Nicotinic Agonist [EPC]
Marketing Start: 03/15/2024

Recall History

No Recall History

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 more than 30 minutes after waking up, use 2 mg nicotine lozenge • if you smoke your first cigarette within 30 minutes of waking up, use 4 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 …

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 and rapid heartbeat • you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of chi…

Frequently Asked Questions

What is Mini Nicotine used for?

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

Is Mini Nicotine a controlled substance?

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

What is the generic name for Mini Nicotine?

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

What is the NDC code for Mini Nicotine 4 mg/1?

The NDC (National Drug Code) for Mini Nicotine 4 mg/1 is 59726-264, listed by P & L Development, LLC.

Product NDC

59726-264

Package NDC

59726-264-27

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)