Drugplain

Habitrol Step 1 21 mg/24h

Nicotine Transdermal System Patch · PATCH, EXTENDED RELEASE · Dr. Reddy's Laboratories Inc.

No Recall History
Plain English

Habitrol Step 1 is a nicotine patch you wear on your skin to help you quit smoking by delivering nicotine slowly over 24 hours. It works by stimulating nicotine receptors in your brain to reduce cravings and withdrawal symptoms associated with quitting cigarettes.

Key Facts

Brand Name
Habitrol Step 1
Generic Name
Nicotine Transdermal System Patch
NDC Code (Product)
55741-448
Manufacturer
Dr. Reddy's Laboratories Inc.
Strength
21 mg/24h
Dosage Form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Marketing Status
Application #
NDA020076
Drug Class
Cholinergic Nicotinic Agonist [EPC]
Marketing Start
07/13/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

product adhesion issue1,174 reports
product quality issue942 reports
treatment noncompliance886 reports
nicotine dependence805 reports
drug ineffective590 reports
overdose357 reports
nausea269 reports
wrong technique in product usage process266 reports
drug dose omission230 reports
headache209 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 • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed self-help guide for complete directions and other information • begin using the patch on your quit day • if you smoke more than 10 cigarettes per day, use the following schedule below: • if you smoke 10 or less cigarettes per day , start with Step 2 for 6 weeks, then Step 3 for 2 weeks • apply one new patch every 24 hours on skin that is dry, clean and hairless • remove backing from patch and immediately press onto skin. Hold for 10 seconds. • wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. • the used patch should be removed and a new one applied to a different skin site at the same time each day • if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning • do not wear more than one patch at a time • do not cut patch in half or into smaller pieces • do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours • to avoid possible burns, remove patch before underg

Warnings

WARNINGS SECTION 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 not controlled with medication. •Nicotine can increase your blood pressure. •an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. •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 a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if •skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rashirregular heartbeat or palpita

Frequently Asked Questions

What is Habitrol Step 1 used for?

Habitrol Step 1 is a nicotine patch you wear on your skin to help you quit smoking by delivering nicotine slowly over 24 hours. It works by stimulating nicotine receptors in your brain to reduce cravings and withdrawal symptoms associated with quitting cigarettes.

Is Habitrol Step 1 a controlled substance?

Habitrol Step 1 is not classified as a controlled substance by the DEA.

What is the generic name for Habitrol Step 1?

The generic name for Habitrol Step 1 is Nicotine Transdermal System Patch. There are 5 other brand versions of Nicotine Transdermal System Patch.

What is the NDC code for Habitrol Step 1 21 mg/24h?

The NDC (National Drug Code) for Habitrol Step 1 21 mg/24h is 55741-448, listed by Dr. Reddy's Laboratories Inc..

Product NDC

55741-448

Package NDC

55741-448-28

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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