Drugplain

Prevacid 30 mg/1

lansoprazole · CAPSULE, DELAYED RELEASE · Takeda Pharmaceuticals America, Inc.

3 Recalls on Record
Plain English

Prevacid is a capsule, delayed release containing lansoprazole at 30 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..

Key Facts

Brand Name
Prevacid
Generic Name
lansoprazole
NDC Code (Product)
64764-046
Manufacturer
Takeda Pharmaceuticals America, Inc.
Strength
30 mg/1
Dosage Form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
NDA020406
Drug Class
Proton Pump Inhibitor [EPC]
Marketing Start
05/10/1995

Recall History

3 Recalls on Record
Class II09/26/2018

GLAXOSMITHKLINE NEBRASKA

CGMP deviations

TerminatedVoluntary: Firm initiated
Class II03/28/2022

Preferred Pharmaceuticals, Inc.

Out of specification results observed in dissolution during long term stability testing.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Dosage & Administration

Directions • adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day curse every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Warnings

Warnings Allergy alert: • do not use if you are allergic to lansoprazole • lansoprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have • liver disease • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you g

Frequently Asked Questions

What is Prevacid used for?

Prevacid contains lansoprazole. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.

Is Prevacid a controlled substance?

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

What is the generic name for Prevacid?

The generic name for Prevacid is lansoprazole. There are 12 other brand versions of lansoprazole.

What is the NDC code for Prevacid 30 mg/1?

The NDC (National Drug Code) for Prevacid 30 mg/1 is 64764-046, listed by Takeda Pharmaceuticals America, Inc..