Drugplain

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg 20 mg/1

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg · CAPSULE, DELAYED RELEASE · MARKSANS PHARMA LIMITED

1 Recall on Record
Plain English

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg is a capsule, delayed release containing esomeprazole magnesium delayed-release capsules, 20 mg at 20 mg/1, taken oral. Manufactured by MARKSANS PHARMA LIMITED.

Key Facts

Brand Name
Esomeprazole Magnesium Delayed-Release Capsules, 20 mg
Generic Name
Esomeprazole Magnesium Delayed-Release Capsules, 20 mg
NDC Code (Product)
25000-075
Manufacturer
MARKSANS PHARMA LIMITED
Strength
20 mg/1
Dosage Form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA217264
Marketing Start
09/30/2023

Recall History

1 Recall on Record
Class II06/10/2015

AstraZeneca Pharmaceuticals LP

Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective8 reports
product substitution issue4 reports
abdominal distension2 reports
nausea2 reports
paraesthesia2 reports
product quality issue2 reports
abdominal pain upper1 reports
abdominal tenderness1 reports
accidental exposure to product packaging1 reports
accidental overdose1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • 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 may take 1 to 4 days for full effect 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 esomeprazole • Esomeprazole may cause severe skin reactions. Symptoms include: o skin reddening o blisters o rash If an allergic reaction occurs, stop use and seek medical attention right away.

Frequently Asked Questions

What is Esomeprazole Magnesium Delayed-Release Capsules, 20 mg used for?

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg contains Esomeprazole Magnesium Delayed-Release Capsules, 20 mg. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.

Is Esomeprazole Magnesium Delayed-Release Capsules, 20 mg a controlled substance?

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg is not classified as a controlled substance by the DEA.

What is the generic name for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg?

The generic name for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg is Esomeprazole Magnesium Delayed-Release Capsules, 20 mg. There are no other listed brand versions of Esomeprazole Magnesium Delayed-Release Capsules, 20 mg.

What is the NDC code for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg 20 mg/1?

The NDC (National Drug Code) for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg 20 mg/1 is 25000-075, listed by MARKSANS PHARMA LIMITED.

Product NDC

25000-075

Package NDC

25000-075-76

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

Data from openFDA · Public domain (CC0 1.0)