Active Ingredient (In Each Capsule)
Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
The following Structured Product Label (SPL) was submitted to the FDA by Camber Consumer Care Inc for the product Esomeprazole Magnesium (NDC 69230-320). 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, uses, warnings, do not use if you have, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
Acid reducer
Allergy alert: Do not use if you are allergic to esomeprazole
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.
• 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.
Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.
call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.
* Please review the disclaimer below.