Esomeprazole Magnesium Delayed-Release Tablets 20 mg *

Manufacturer
CVS Pharmacy, Inc. | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2024-07-09
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:54

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientESOMEPRAZOLE MAGNESIUM DIHYDRATE
Label structure13 sections

Indications and 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  

Dosage and administration

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 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 swallow whole. Do not crush or chew tablets. do not use for more than 14 days unless directed by your doct...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)


*Esomeprazole 20 mg
(Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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:

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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 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
  • swallow whole. Do not crush or chew tablets.
  • 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.

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, 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)

Tips for Managing Heartburn

  • Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
  • Eat slowly and do not eat big meals.
  • Do not eat late at night or just before bedtime.
  • Do not lie flat or bend over soon after eating.
  • Raise the head of your bed.
  • Wear loose-fitting clothing around your stomach.
  • If you are overweight, lose weight.
  • If you smoke, quit smoking.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVSHealth®

NDC 51316-088-01

Treats Frequent Heartburn
May take 1 to 4 days for full effect                            24
Esomeprazole                                                            HOUR
Magnesium
DELAYED-RELEASE TABLETS 20 mg*

Acid reducer

14 TABLETS
One 14-day course of treatment


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVSHealth®

Compare to the active
ingredient in Nexium® 24 HR**

NDC 51316-088-01

Treats Frequent Heartburn                             24

May take 1 to 4 days for full effect                HOUR

Esomeprazole
Magnesium
DELAYED-RELEASE
TABLETS 20 mg*

Acid reducer

See new warning
information

14
TABLETS
(1 bottle inside)
One 14-day course
of treatment                            Actual Size

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN2
433733esomeprazole 20 MG Delayed Release Oral TabletSCD2
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ESOMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-088-01Esomeprazole Magnesium1 in 1 CARTONTABLET, DELAYED RELEASE12
51316-088-01Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE142
51316-088-05Esomeprazole Magnesium3 in 1 CARTONTABLET, DELAYED RELEASE32
51316-088-05Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-088ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [CVS PHARMACY, INC.]2Current NDC, 4 package rows20240710_1867185e-9c34-c8cc-e063-6394a90ab3b1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-08851316-088-01, 51316-088-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214473-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2026-08-18 06:07:402026-07A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-128072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214473-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2023-07-12a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacy, Inc.1867185e-9c34-c8cc-e063-6394a90ab3b12024-07-09WarningsExact identifier
ndc (package): 51316-088-01
ndc (package): 51316-088-05
ndc (product): 51316-088
ndc11 (package): 51316008801
ndc11 (package): 51316008805
spl id: c7b8460b-d1da-41d9-b644-157718295382
spl set id: 1867185e-9c34-c8cc-e063-6394a90ab3b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.