Active Ingredient (In Each Capsule)
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
The following Structured Product Label (SPL) was submitted to the FDA by Ohm Laboratories Inc. for the product Esomeprazole (NDC 51660-027). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, use, warnings, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are:, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
Acid reducer
Allergy alert: Do not use if you are allergic to esomeprazole
Do not use if you have:
These may be signs of a serious condition. See your doctor.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.
Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.
TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.
Tips for Managing Heartburn
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
R0320
†Compare To
the active ingredient of
Nexium® 24HR
NDC 51660-027-44
Treats Frequent Heartburn
24
HR
Esomeprazole Magnesium
Delayed-Release Capsules
USP, 20 mg* / Acid Reducer
May take 1 to 4 days for full effect
ohm®
42 CAPSULES
Three 14-day courses of treatment
3 x 14 Count Bottles Inside
* Please review the disclaimer below.