Drug Facts
Active ingredient (in each capsule)
*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)
Esomeprazole Magnesium Capsule, Delayed Release
FDA Label NDC 69842-248
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Esomeprazole Magnesium (NDC 69842-248). 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 drug facts, 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.
Label Section Quick Index
Purpose
Acid reducer
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
Warnings
Allergy alert: Do not use if you are allergic to esomeprazole
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)
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
- 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
- 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.
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20-25°C (68-77°F)
- Meets USP dissolution test 2
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
Other information
Inactive Ingredients
colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.
Questions or comments?
call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike,
Lawrenceville, NJ 08648
Made in India
Code: TS/DRUGS/22/2009
Package Label-Principal Display Panel - 20 Mg (14 Capsule Container Label)
CVSHealth. Package Label-principal Display Panel (20 mg (14 Capsule Container Label))
Treats Frequent Heartburn
May take 1 to 4 days for full effect
Esomeprazole Magnesium
Delayed-Release Capsules USP 20 mg*
Acid Reducern
14 CAPSULES
One 14-day course of treatment 
Package Label-Principal Display Panel - 20 Mg (14 Capsule Container Carton)
CVSHealthTM
Compare to the active
ingredient in Nexium® 24 HR**
Treats Frequent Heartburn
May take 1 to 4 days for full effect
Esomeprazole Magnesium
DELAYED-RELEASE
CAPSULES USP 20 mg*
Acid Reducer
See new warning information
14 CAPSULES
One 14-day Course
of treatment
Package Label-principal Display Panel (20 mg (14 Capsule Container Carton))
CVSHealthTM
Compare to the active
ingredient in Nexium® 24 HR**
Treats Frequent Heartburn
May take 1 to 4 days for full effect
Esomeprazole Magnesium
DELAYED-RELEASE
CAPSULES USP 20 mg*
Acid Reducer Package Label-principal Display Panel (20 mg (14 Capsule Container Carton))
See new warning information
42 CAPSULES
(3 bottles of 14 each)
Two 14-day courses of treatment 
Package Label-Principal Display Panel - 20 Mg (28 Capsule Container Carton)
CVSHealthTM
Compare to the active
ingredient in Nexium® 24 HR**
Treats Frequent Heartburn
May take 1 to 4 days for full effect
Esomeprazole Magnesium
DELAYED-RELEASE
CAPSULES USP 20 mg*
Acid Reducer Package Label-principal Display Panel (20 mg (28 Capsule Container Carton))
See new warning information
28 CAPSULES
(2 bottles of 14 each)
Two 14-day courses of treatment 
* Please review the disclaimer below.
