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Natural Product Number (NPN):

80025660

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Chu Nicotine Anti Smoking Aid, 2mg ;
EQUATE ;
EXACT brand ;
Life Brand Nicotine Chill Mint ;
Life Brand Nicotine Fresh Fruit ;
Life Brand Nicotine Fresh Mint ;
Life Brand Nicotine Ice Mint ;
Nic Hit Smoking Cessation Aid ;
Nicotine Gum ;
Nicotine Gum Preferred Pharmacy Nicotine Gum ;
Nicotine Polacrilex Gum USP ;
Ultra Chill Mint ;
Ultra Fresh Fruit ;
Ultra Fresh Mint ;
Ultra Ice Mint

Licence holder:

Alkalon A/S

Dosage Form:

Gum

Recommended route of administration:

Oral

Recommended use or purpose:

Anti Smoking Aid. As a temporary aid to those who want to stop smoking cigarettes or break the cigarette habit, when used as part of smoking cessation program (Reference : Labelling Standard).

Risk Information:

Cautions and Warnings 

Do not use if: You are an occasional or non-smoker. You are under 18 years of age. Also: Do not smoke, use nicotine patches or any other form of nicotine while using nicotine gum. Keep out of the reach of children and pets. Consult your doctor if you have difficulty in reducing the quantity of gum. 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. Consult your dentist or doctor if injury or irritation to the mouth, teeth or gum around dentures occurs. 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. Young children are especially sensitive to the effects of even small doses of nicotine. Nicotine gum is designed to release nicotine only when chewed. No harmful effects should occur if you accidently swallow a piece.

Contra-Indications 

Do not use if you have temporomandibular joint disorder. Do not use if you are pregnant or nursing a child. Avoid becoming pregnant while using nicotine gum. If you think you are pregnant, stop using the gum at once and see your doctor. Discontinue using nicotine gum and consult your doctor if irregular heart beat, chest pain or leg pain occurs or if severe persistent stomach upset (indigestion, heartburn) develops.

Known Adverse Reactions 

Side effects which may be sign of improper chewing are light-headedness, nausea and hiccups. Symptoms of an over dose include nausea, abdominal pain, vomiting, diarrhoea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, rapid heartbeat, difficulty breathing and marked weakness.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
1-Methyl-2-(3-pyridyl)pyrrolidine	2.0 mg

List of non-medicinal ingredients:

• Acacia Gum
• Acesulfame-K
• Acetylated Monoglycerides
• Acetylated diglycerides
• Aspartame
• Berry flavour
• Blackberry flavour
• Butyl Rubber
• Butylated hydroxytoluene
• Calcium carbonate
• Carnauba Wax
• Chewing Gum Base
• Cinnamon Flavour
• Citral
• Citronellyl Acetate
• Coffee flavour
• Ethyl menthane carboxamide
• Fruit flavour
• Glyceryl Monostearate
• Hydrogenated vegetable oil
• Isopulegol
• L-menthol
• Lecithin
• Lemon-lime flavour
• Linalool
• Linalyl Acetate
• Maize
• Maltitol syrup
• Mango flavour
• Mannitol
• Menthol
• Orange Oil
• Peppermint oil
• Polyisobutylene
• Polyvinyl acetate
• Pomegranate flavour
• Rapeseed oil
• Silicon Dioxide
• Sodium bicarbonate
• Sodium carbonate
• Sorbitol
• Talc
• Terpene Resin, Synthetic
• Titanium dioxide
• Tricalcium Phosphate
• Wintergreen flavour
• Xylitol
• dl-limonene
• l-Menthol

Date of licensing:

2011-06-07

Revised date of licence:

2022-11-13