nicotine polacrilex

FDA Drug Profile — Nicotine, equate nicotine, Nicotine Mini, Nicorette Original, nicotine

nicotine polacrilex is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Nicotine, equate nicotine, Nicotine Mini. Available dosage forms: gum, chewing, lozenge.

Drug Details

Generic Name
nicotine polacrilex
Brand Names
Nicotine, equate nicotine, Nicotine Mini, Nicorette Original, nicotine, NICORETTE, NICOTINE, up and up nicotine, basic care nicotine, Nicotine Sugar Free, topcare nicotine, EQUATE NICOTINE, Mini Nicotine, BLIP, signature care nicotine, GOOD SENSE NICOTINE, good sense nicotine, Nicorette 4mg White Ice Mint Gum, Lil Drug Store, Nicorette Fruit Chill, Nicorette Peppermint, nicotine lozenge, Nicorette Spearmint Burst, COATED NICOTINE
Application Number
ANDA074707
Sponsor
The Kroger Co.
NDC Codes
50
Dosage Forms
GUM, CHEWING, LOZENGE
Routes
ORAL, BUCCAL
Active Ingredients
NICOTINE

Indications and Usage

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

Warnings

Warnings 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. Ask a doctor before use if you have • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. • high blood pressure con controlled with medication. Nicotine can increase your blood pressure. • stomach ulcer or diabetes • history of seizures 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, and rapid heartbeat • you have symptoms of an allergic reaction (such as difficulty breathing or rash) 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 overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222)