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Natural Product Number (NPN):

80109815

Market status:

Marketed

Licence Status:

Active

Brand name(s):

NICOMELTS 4 mg ;
NICOMELTS MAX 4 mg ;
NICOMELTZ 4 mg ;
Nutrameltz Nicotine 4mg ;
Nutrameltz Nicotine max 4mg

Licence holder:

Nutricede Inc. dba NICOMELT

Dosage Form:

Tablet, orally disintegrating

Recommended route of administration:

Sublingual

Recommended use or purpose:

A form of Nicotine Replacement Therapy. Stop smoking aid. As a temporary aid to those who want to stop smoking cigarettes or break the cigarette habit, when used as part of a smoking cessation program. Can help you stop smoking by reducing withdrawal symptoms and nicotine cravings. The effectiveness of this product is directly related to your motivation to stop smoking. Consult your pharmacist or doctor regarding the availability of smoking cessation programs in your area.

Risk Information:

Cautions and Warnings 

Keep out of the reach of children and pets. Symptoms of an overdose include nausea, abdominal pain, vomiting, diarrhea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, rapid heartbeat, difficulty breathing and marked weakness. Consult your dentist or doctor if injury or irritation to the mouth, teeth or gum around dentures occurs. Consult your doctor if you have difficulty in reducing the quantity of tablets. In case of overdose or if a child chews or swallows one or more pieces of nicotine tablets, contact your doctor or local poison control centre at once. Young children are especially sensitive to the effects of even small doses of nicotine. Consult your doctor before using this product if you have or have had heart, thyroid, circulation, stomach, or throat or mouth problems, high blood pressure, or if you are taking insulin or any prescription medicine.

Contra-Indications 

Do not smoke, use nicotine patches or any other form of nicotine while using nicotine tablets. Do not use if you are a non-smoker or occasional smoker, or if you are under 18 years of age. Do not use if you are pregnant of breastfeeding. Avoid becoming pregnant while using nicotine tablets. If you think you are pregnant, stop using nicotine tablets at once and see your doctor.

Known Adverse Reactions 

Discontinue using nicotine tablets and consult your doctor if irregular heart beat, chest pain or leg pain occurs or if severe persistent stomach upset (indigestion, heartburn) develops. Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
1-Methyl-2-(3-pyridyl)pyrrolidine	4.0 mg

List of non-medicinal ingredients:

• Calcium silicate
• Citric acid
• Crospovidone
• D-Allulose
• D-Mannitol
• Flavour
• Hydroxypropylcellulose
• Magnesium stearate
• Monk fruit extract
• Silicon dioxide
• Xylitol
• beta-Cyclodextrin

Date of licensing:

2021-05-10

Revised date of licence:

2024-11-04