Perrigo Nicotine Lozenge Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 2 mg (nicotine)

Purpose

Stop smoking aid

Uses

• reduces withdrawal symptoms, including nicotine craving associated with quitting smoking

Warnings

Enter section text here

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• a sodium-restricted diet
• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
• stomach ulcer or diabetes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug
• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth problems occur
• persistent indigestion or severe sore throat occurs
• irregular heartbeat or palpitations occur
• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdoe, get medical help or contact a Poison Control Center right away.

Directions

• if you are under 18 years of age, ask a doctor before use
• before using this product, read the enclosed User’s Guide for complete directions and other important information
• stop smoking completely when you begin using the lozenge
• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge
• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

Other information

• each lozenge contains: sodium 15 mg
• Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge
• sugar alcohol content: 1 g mannitol per lozenge
• store at 20-25°C (68-77°F)
• keep vial closed and protect from light

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum