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Natural Product Number (NPN):

80119891

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Rogue Gum ;
Rogue Gum, fruit ;
Rogue Gum, peppermint ;
Rogue Gum, wintergreen

Licence holder:

Rogue Holdings, LLC

Dosage Form:

Gum, chewing

Recommended route of administration:

Buccal

Recommended use or purpose:

ROGUE GUM can help you stop smoking by reducing withdrawal symptoms and nicotine cravings. Using ROGUE GUM enables you to reduce the daily number of cigarettes smoked to ease the transition into a smoke-free lifestyle. ROGUE GUM can 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.

Risk Information:

Cautions and Warnings 

Consult your doctor before using this product if you have or have had heart, thyroid, circulation, stomach, throat or mouth problems, high blood pressure, or if you are taking insulin or any prescription medicine. Consult your dentist if injury or irritation to the mouth, teeth or gum around dentures occurs. Young children are especially sensitive to the effects of even small doses of nicotine. In case of overdose or if a child chews or swallows one or more pieces of ROGUE GUM, contact your doctor or local poison control center at once. Stop using ROGUE GUM and consult your doctor if irregular heartbeat, chest or leg pain occurs. Stop using ROGUE GUM and consult your doctor if severe or persistent stomach upset (indigestion, heart burn) develops. Stop using ROGUE GUM and consult your doctor if you develop symptoms of overdose such as nausea, abdominal pain, vomiting, diarrhea, cold sweats, dizziness, disturbed hearing and vision, mental confusion, marked weakness, excessive salivation, rapid heartbeat or difficulty breathing. Keep out of the reach of children and pets. Consult your doctor if you have difficulty in reducing the quantity of gum. Avoid becoming pregnant while using nicotine gum. If you think you are pregnant, stop using nicotine gum at once and see your doctor. 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.

Contra-Indications 

Do not use if you have temporomandibular joint disorder (TMJ disorder). Do not smoke or use other forms of nicotine while using ROGUE GUM. Do not use if you are under 18 years of age, are pregnant or breastfeeding, are an occasional or non-smoker or are allergic to nicotine or to any of the non-medicinal ingredients in the product.

Known Adverse Reactions 

ROGUE GUM can occasionally cause side effects such as mouth or throat irritation, headaches, hiccups, or upset stomach, especially if consumed too quickly or incorrectly (such as by swallowing).

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
2-Propenoic acid, 2-methyl-, polymer with diethenylbenzene, compd. with 3-((2S)-1-methyl-2-pyrrolinidinyl)pyridine	4.0 mg		4.0   mg Nicotine

List of non-medicinal ingredients:

• Acesulfame potassium
• Carnauba Wax
• Colloidal silicon dioxide
• D&C Yellow No. 10
• FD&C Blue No. 1 Aluminum Lake
• FD&C Red No. 40
• FD&C Yellow No. 5 Aluminum Lake
• FD&C Yellow No. 6 Aluminum Lake
• Flavour
• Gum arabic
• Hypromellose
• Maltitol solution
• Peppermint flavour
• Polyethylene glycol
• Purified water
• Sodium carbonate
• Titanium dioxide
• Tutti fruitti flavour
• Wintergreen flavour
• d-Menthol

Date of licensing:

2022-07-13

Revised date of licence:

2023-01-16