ESOMEPRAZOLE MAGNESIUM MINIS

ESOMEPRAZOLE MAGNESIUM MINIS is an FDA-registered drug product whose active ingredient is ESOMEPRAZOLE MAGNESIUM DIHYDRATE. It is labelled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 51316-174, application ANDA207193, label effective 20260727. It is one of 2 FDA drug label records sharing the active ingredient ESOMEPRAZOLE MAGNESIUM DIHYDRATE. 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 ESOMEPRAZOLE MAGNESIUM DIHYDRATE 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.

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

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 Allergy alert: • Do not use if you are allergic to esomeprazole. • Esomeprazole 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 • 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 right away (1-800-222-1222).

FDA lists 2 drug label records with ESOMEPRAZOLE MAGNESIUM DIHYDRATE 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.

What is ESOMEPRAZOLE MAGNESIUM MINIS used for?
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

Who makes ESOMEPRAZOLE MAGNESIUM MINIS?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED is the labeler of record for ESOMEPRAZOLE MAGNESIUM MINIS. 2 FDA label records share the active ingredient ESOMEPRAZOLE MAGNESIUM DIHYDRATE, 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 ESOMEPRAZOLE MAGNESIUM MINIS 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 ESOMEPRAZOLE MAGNESIUM MINIS 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 ESOMEPRAZOLE MAGNESIUM DIHYDRATE?
Yes. 2 FDA drug label records list ESOMEPRAZOLE MAGNESIUM DIHYDRATE 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 ESOMEPRAZOLE MAGNESIUM MINIS been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.