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Natural Product Number (NPN):

80000402

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Nicotinell Gum 4 mg ;
Thrive Gum 4mg

Licence holder:

Haleon Canada ULC

Dosage Form:

Chewing Gum

Recommended route of administration:

Buccal

Recommended use or purpose:

THRIVE GUM / NICOTINELL GUM can help you stop smoking by reducing withdrawal symptoms and nicotine cravings. Using THRIVE GUM / NICOTINELL GUM enables you to reduce the daily number of cigarettes smoked to ease the transition into a smoke-free lifestyle. Although smoking cessation is preferable, THRIVE GUM / NICOTINELL GUM can also be used in cases when you need to temporarily refrain from smoking, for example, in smoke-free areas, airplanes, etc. or in other situations when you wish to avoid smoking. Product effectiveness is directly related to your motivation to stop smoking. Consult your pharmacist or doctor regarding the availability of smoking cessation programs in your area for counselling and support. THRIVE GUM works within 15 minutes. THRIVE GUM calms cravings for up to one hour.

Risk Information:

Cautions and Warnings 

Do Not Use If You: Are under 18 years of age. Have a jaw disorder. Are an occasional or non-smoker. Are pregnant or nursing. Avoid becoming pregnant while using THRIVE GUM. If you think you may be pregnant, stop using at once and see your doctor. Are allergic to nicotine or any of the other ingredients in the gum. Consult your doctor before use if you have ever experienced seizures. Do not smoke or use other nicotine containing products while using THRIVE GUM. Consult your doctor if you have difficulty in reducing the quantity of pieces used within three months, and do not use for more than 6 months without consulting a physician. If a child chews or swallows one or more pieces of THRIVE GUM contact your doctor or local poison control center at once even if there are no symptoms. Young children are especially sensitive to the effects of even small doses of nicotine. Nicotine can be lethal to children and pets.

Contra-Indications 

Ask Your Doctor Before Use If You: Have/have had heart, thyroid, circulation, stomach, throat or mouth problems, high blood pressure or stroke. Take insulin or any prescription medicine. Have ever experienced seizures.

Known Adverse Reactions 

Consult your dentist or doctor if injury or irritation to the mouth, teeth or gum around dentures occurs. As with any gum, chewing can cause dental fillings to loosen and aggravate mouth, tooth and jaw problems. It may also stick to dental work. THRIVE GUM can cause side effects such as: feeling sick, mouth or throat soreness, upset stomach and other stomach problems, hiccups, constipation, dry mouth, headache, light-headedness, insomnia, cough especially if chewed too quickly or not chewed correctly. Stop using THRIVE GUM and seek medical advice if: You develop symptoms of overdose such as nausea, abdominal pain, vomiting, diarrhea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, marked weakness, rapid heart beat or difficulty breathing. Irregular heart beat, chest pain or leg pain occurs or if severe or persistent stomach upset (indigestion, heart burn) develops. You develop severe allergic symptoms of which include sudden wheeziness or tightness of chest, rash and feeling faint. Common side effects of quitting smoking may include: irritability, trouble sleeping, increased appetite and headaches.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Nicotine	4.0 mg		4.0   mg nicotine

List of non-medicinal ingredients:

• Acesulfame K (see Acesulfame Potassium)
• Calcium carbonate
• Carnauba Wax
• Chewing Gum Base
• Flavour
• Gelatin
• Glycerin
• Mannitol
• Menthol
• Mint Flavour
• Purified water
• Sodium bicarbonate
• Sodium carbonate (anhydrous)
• Sorbitol
• Sucralose
• Talc
• Titanium dioxide
• Xylitol

Date of licensing:

2005-05-12

Revised date of licence:

2021-08-31