nicotine polacrilex

FDA Drug Profile — Nicotine, nicotine, HEB Nicotine, Nicotine Mini, Members Mark Nicotine

Drug Details

Generic Name
nicotine polacrilex
Brand Names
Nicotine, nicotine, HEB Nicotine, Nicotine Mini, Members Mark Nicotine, Nicotine Sugar Free, Mini Nicotine, BLIP, Nicorette White Ice Mint, NICORETTE, Nicorette Peppermint, good sense nicotine, NICOTINE, foster and thrive nicotine, basic care nicotine, topcare nicotine, Nicorette Cinnamon Surge, good neighbor pharmacy nicotine, Nicorette Fruit Chill, members mark nicotine, up and up citrus mini nicotine
Application Number
ANDA210711
Sponsor
Fertin Pharma A/S
NDC Codes
50
Dosage Forms
GUM, CHEWING, LOZENGE
Routes
ORAL
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 • 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 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, teeth or jaw problems occur • 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. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).