Omeprazole Delayed-Release

Omeprazole Delayed-Release is an FDA-registered drug product whose active ingredient is OMEPRAZOLE. It is labelled by H-E-B taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 37808-569, application ANDA218829, label effective 20260429. It is one of 75 FDA drug label records sharing the active ingredient OMEPRAZOLE. 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 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 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 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 - swallow 1 tablet with a glass of water before eating in the morning - take every day for 14 days - do not take more than 1 tablet a day - do not use for more than 14 days unless directed by your doctor - swallow whole. Do not chew or crush tablets. 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. Heartburn in children may sometimes be caused by a serious condition.

Warnings Allergy alert: Do not use if you are allergic to omeprazole. Omeprazole may cause severe skin reactions. Symptoms may include: - skin reddening - blisters - rash If an allergic reaction occurs, stop use and seek medical attention 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: 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 get diarrhea you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

FDA lists 75 drug label records with OMEPRAZOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

4 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 Delayed-Release used for?
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 Delayed-Release?
H-E-B is the labeler of record for Omeprazole Delayed-Release. 75 FDA label records share the active ingredient OMEPRAZOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Omeprazole Delayed-Release 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 Delayed-Release 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.

Are there other products containing OMEPRAZOLE?
Yes. 75 FDA drug label records list OMEPRAZOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Omeprazole Delayed-Release been recalled?
4 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.