Esomeprazole Magnesium

Manufacturer
Dr. Reddys Laboratories Inc | Reed Lane Inc
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:57

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientEsomeprazole Magnesium
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 doctor...

Storage and handling

store at 20°C to 25°C (68°F to 77°F)

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

*Esomeprazole 20 mg

(Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate, 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 lightheadness·

  • 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

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

SPL UNCLASSIFIED SECTION

  • read directions and warnings before use·
  • keep the carton. It contains important information

Storage

STORAGE AND HANDLING SECTION

  • store at 20°C to 25°C (68°F to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, glyceryl monostearate, hypromellose, iron oxide red, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate 80, simethicone, sodium stearyl fumarate, sugar spheres (contains sucrose and maize starch), talc, titanium dioxide, triethyl citrate

Questions

OTC - QUESTIONS SECTION

call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

SPL UNCLASSIFIED SECTION

Tips for Managing Heartbun

  • Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chDistocolate, 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.

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Issued: 10/2023

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container 14's count:

containercontainer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton 14's count:

carton1carton1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN1
433733esomeprazole 20 MG Delayed Release Oral TabletSCD1
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY1

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-119-27Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141
75907-119-27Esomeprazole Magnesium2 in 1 CARTONTABLET, DELAYED RELEASE21
75907-119-33Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141
75907-119-33Esomeprazole Magnesium3 in 1 CARTONTABLET, DELAYED RELEASE31
75907-119-52Esomeprazole Magnesium1 in 1 CARTONTABLET, DELAYED RELEASE11
75907-119-52Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-119ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [DR. REDDYS LABORATORIES INC]1Current NDC, 6 package rows20231230_2c2bcdf7-689a-47bd-1713-0ea74f72044b.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75907-11975907-119-52, 75907-119-27, 75907-119-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
A211571-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14

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
2026-09-14 22:38:342026-08A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1484e616aacf4f…
2026-08-18 06:07:402026-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14a50c72e98297…

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 MAGNESIUMDr. Reddys Laboratories Inc2c2bcdf7-689a-47bd-1713-0ea74f72044b2023-12-14WarningsExact identifier
ndc (package): 75907-119-52
ndc (package): 75907-119-27
ndc (package): 75907-119-33
ndc (product): 75907-119
ndc11 (package): 75907011933
ndc11 (package): 75907011952
ndc11 (package): 75907011927
spl id: a40c48e8-93c4-8b65-6b4d-a6d236e39c38
spl set id: 2c2bcdf7-689a-47bd-1713-0ea74f72044b

Reported adverse events (FAERS/openFDA)#

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