Drugplain

equate lansoprazole 15 mg/1

lansoprazole · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · Wal-Mart Stores Inc

1 Recall on Record
Plain English

equate lansoprazole is a tablet, orally disintegrating, delayed release containing lansoprazole at 15 mg/1, taken oral. Manufactured by Wal-Mart Stores Inc.

Key Facts

Brand Name
equate lansoprazole
Generic Name
lansoprazole
NDC Code (Product)
49035-373
Manufacturer
Wal-Mart Stores Inc
Strength
15 mg/1
Dosage Form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
NDA208025
Drug Class
Proton Pump Inhibitor [EPC]
Marketing Start
03/19/2019

Recall History

1 Recall on Record
Class II01/03/2014

Dr. Reddy's Laboratories, Inc.

Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

diarrhoea6,411 reports
dyspnoea5,814 reports
nausea5,524 reports
fatigue5,118 reports
off label use5,113 reports
vomiting5,056 reports
acute kidney injury4,919 reports
chronic kidney disease4,672 reports
malaise4,569 reports
headache4,561 reports

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 course 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 equate lansoprazole used for?

equate lansoprazole contains lansoprazole. It is a tablet, orally disintegrating, delayed release taken oral. Consult your doctor for specific uses.

Is equate lansoprazole a controlled substance?

equate lansoprazole is not classified as a controlled substance by the DEA.

What is the generic name for equate lansoprazole?

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

What is the NDC code for equate lansoprazole 15 mg/1?

The NDC (National Drug Code) for equate lansoprazole 15 mg/1 is 49035-373, listed by Wal-Mart Stores Inc.