Drugplain

Nicotine 7 mg/24h

Nicotine · PATCH · Meijer, Inc.

10 Recalls on Record
Plain English

Nicotine is a patch containing nicotine at 7 mg/24h, taken transdermal. Manufactured by Meijer, Inc..

Key Facts

Brand Name
Nicotine
Generic Name
Nicotine
NDC Code (Product)
79481-0054
Manufacturer
Meijer, Inc.
Strength
7 mg/24h
Dosage Form
PATCH
Route
TRANSDERMAL
Marketing Status
Application #
ANDA074612
Drug Class
Cholinergic Nicotinic Agonist [EPC]
Marketing Start
03/20/2024

Recall History

10 Recalls on Record
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as one of the following drugs: ESTRADIOL, Tablet, 0.5 mg, NDC 00555089902, Pedigree: AD30993_11, EXP: 5/9/2014; ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: W002973, EXP: 6/11/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: W003730, EXP: 6/26/2014; ESZOPICLONE, T

TerminatedVoluntary: Firm initiated
Class III02/20/2014

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

TerminatedVoluntary: Firm initiated
Class III02/20/2014

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

TerminatedVoluntary: Firm initiated
Class III02/20/2014

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup:NICOTINE POLACRILEX, GUM, 2 mg may have potentially been mislabeled as one of the following drugs: FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: AD33897_22, EXP: 5/9/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 60505313001, Pedigree: W003099, EXP: 6/13/2014.

TerminatedVoluntary: Firm initiated
Class III08/19/2014

Perrigo Holland Inc

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

TerminatedVoluntary: Firm initiated
Class III02/20/2014

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

TerminatedVoluntary: Firm initiated
Class III02/20/2014

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

TerminatedVoluntary: Firm initiated
Class III02/20/2014

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

TerminatedVoluntary: Firm initiated
Class III05/14/2026

AVEVA Drug Delivery Systems, Inc.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,059 reports
nausea1,808 reports
nicotine dependence1,460 reports
headache984 reports
product adhesion issue921 reports
dizziness886 reports
overdose864 reports
malaise858 reports
macular degeneration788 reports
wrong technique in product usage process771 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions 2 mg : if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day 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: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozen

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 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 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 ch

Frequently Asked Questions

What is Nicotine used for?

Nicotine contains Nicotine. It is a patch taken transdermal. Consult your doctor for specific uses.

Is Nicotine a controlled substance?

Nicotine is not classified as a controlled substance by the DEA.

What is the generic name for Nicotine?

The generic name for Nicotine is Nicotine. There are 11 other brand versions of Nicotine.

What is the NDC code for Nicotine 7 mg/24h?

The NDC (National Drug Code) for Nicotine 7 mg/24h is 79481-0054, listed by Meijer, Inc..