nicotine
nicotine is listed in the FDA National Drug Code directory with 35 NDC codes, marketed under brand names including nicotine, Nicotine transdermal system, Medline. Available dosage forms: patch, extended release, gum, chewing, lozenge, patch, spray, metered.
Drug Details
- Generic Name
- nicotine
- Brand Names
- nicotine, Nicotine transdermal system, Medline, NICODERM CQ, Nicotine, signature care nicotine, Kirkland Signature Nicotine, nicotine polacrilex, quit smoking patches, SEFUDUN QUIT SMOKING NICOTINE PATCHES, Nicotrol, nicotine transdermal system
- Application Number
- ANDA206393
- Sponsor
- Haleon US Holdings LLC
- NDC Codes
- 35
- Dosage Forms
- PATCH, EXTENDED RELEASE, GUM, CHEWING, LOZENGE, PATCH, SPRAY, METERED, KIT
- Routes
- ORAL, TRANSDERMAL, TOPICAL, NASAL
- 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)