foster and thrive nicotine 4 mg/1

Nicotine Polacrilex · LOZENGE · Strategic Sourcing Services LLC

No Recall History

Plain English

foster and thrive nicotine is a lozenge containing nicotine polacrilex at 4 mg/1, taken oral. Manufactured by Strategic Sourcing Services LLC.

Key Facts

Brand Name: foster and thrive nicotine
Generic Name: Nicotine Polacrilex
NDC Code (Product): 70677-1179
Manufacturer: Strategic Sourcing Services LLC
Strength: 4 mg/1
Dosage Form: LOZENGE
Route: ORAL
Marketing Status
Application #: ANDA203690
Drug Class: Cholinergic Nicotinic Agonist [EPC]
Marketing Start: 10/16/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,396 reports

nausea699 reports

nicotine dependence608 reports

macular degeneration564 reports

wrong technique in product usage process419 reports

oral discomfort329 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. Pi…

Frequently Asked Questions

What is foster and thrive nicotine used for?

foster and thrive nicotine contains Nicotine Polacrilex. It is a lozenge taken oral. Consult your doctor for specific uses.

Is foster and thrive nicotine a controlled substance?

foster and thrive nicotine is not classified as a controlled substance by the DEA.

What is the generic name for foster and thrive nicotine?

The generic name for foster and thrive nicotine is Nicotine Polacrilex. There are 12 other brand versions of Nicotine Polacrilex.

What is the NDC code for foster and thrive nicotine 4 mg/1?

The NDC (National Drug Code) for foster and thrive nicotine 4 mg/1 is 70677-1179, listed by Strategic Sourcing Services LLC.

Product NDC

70677-1179

Package NDC

70677-1179-1

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)