Omeprazole 20 mg

Omeprazole 20 mg is an FDA-registered drug product whose active ingredient is OMEPRAZOLE 20 MG. It is labelled by MARKSANS PHARMA LIMITED taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 25000-094, application ANDA218829, label effective 20260805. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing OMEPRAZOLE 20 MG are most often described in connection with: treats frequent, heartburn occurs, days week, immediate relief, full effect. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USE(S) 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

DIRECTIONS Directions • for 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; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment o swallow 1 tablet with a glass of water before eating in the morning o take every day for 14 days o do not take more than 1 tablet a day o do not use for more than 14 days unless directed by your doctor o swallow whole. Do not chew, crush, or suck tablets . Repeated 14-Day Courses (if needed) o you may repeat a 14-day course every 4 months o 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. Heartburn in children may sometimes be caused by a serious condition.

WARNINGS Warnings Allergy alert: • Do not use if you are allergic to omeprazole. • Omeprazole may cause severe skin reactions. Symptoms may include: o skin reddening o blisters o rash If an allergic reaction occurs, stop use and seek medical help right away.

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Omeprazole 20 mg used for?
USE(S) 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

Who makes Omeprazole 20 mg?
MARKSANS PHARMA LIMITED is the labeler of record for Omeprazole 20 mg.

What form does Omeprazole 20 mg come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Omeprazole 20 mg prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Omeprazole 20 mg been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.