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Natural Product Number (NPN):

80112518

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Solace Chew ;
Fre ;
Solace

Licence holder:

10233625 Canada Corp (dba ReCreation Marketing)

Dosage Form:

Gum, chewing

Recommended route of administration:

Buccal

Recommended use or purpose:

Reduces withdrawal symptoms associated with quitting smoking. .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.

Risk Information:

Cautions and Warnings 

Also, if you have had stomach ulcer or diabetes, a sodium restricted diet, heart disease, recent heart attack, or irregular heartbeat (Nicotine can increase heart rate). Consult your dentist or doctor if injury or irritation to the mouth, teeth or gum around dentures occurs. Consult your doctor before using this product if you have or have had heart, thyroid, circulation, stomach, or throat or mouth problems, angina, coronary artery disease, peripheral vascular disease, irregular heartbeat, high blood pressure, or if you are taking insulin or any prescription medicine. Consult your doctor if you have difficulty in reducing the quantity of gum. Discontinue use and consult your doctor if irregular heartbeat, chest pain or leg pain occurs or if severe persistent stomach upset (indigestion, heartburn) develops. Do not use for more than six months without consulting a doctor. In case of overdose or if a child chews or swallows one or more pieces of nicotine gum, contact your doctor or local poison control centre at once. Keep out of the reach of children and pets. Symptoms of an overdose include nausea, abdominal pain, vomiting, diarrhoea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, rapid heartbeat, difficulty breathing and marked weakness.

Contra-Indications 

Do not smoke, chew tobacco, use nicotine patches, or any other form of nicotine while using this nicotine gum product. Do not use if: You are under 18 years of age. Do not use if: You have temporomandibular joint disorder (TMJ disorder).

Known Adverse Reactions 

The following adverse reactions have been reported: hiccups, stomach problems, heartburn and weight gain. Also, nicotine chewing can cause dental fillings to loosen, aggravate other mouth, tooth and jaw problems.

List of medicinal ingredients:

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

List of non-medicinal ingredients:

• Acacia
• Acesulfame potassium
• Blue 1
• Calcium carbonate
• Carnauba Wax
• Cinnamon flavour
• Flavour
• Gum base
• Maltitol Syrup
• Mint flavour
• Natural Fruit Flavour
• Red 40 lake
• Saccharin
• Sodium bicarbonate
• Sodium carbonate
• Sorbitol
• Sucralose
• Talc
• l-Menthol

Date of licensing:

2021-08-31

Revised date of licence: