Finished product reference

Nicotine

Lozenge · Oral · 4 mg

List code
51793
Salt form
Polacrilex
Pharmacologic class
Cholinergic Nicotinic Agonist
0

Indications

Use • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Dosage and administration (summary)

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 …

Warnings and precautions

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.

Storage and supply

Other information • each lozenge contains: sodium 17 mg • Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge • sugar alcohol content: 1 g mannitol per lozenge • store at 68-77°F (20-25°C) • keep vial tightly closed and protect from light

Source: Nicotine Polacrilex (Nicotine) — US FDA prescribing information, 2026-07-20, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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