FDA.reportPublic FDA data

Esomeprazole Magnesium

Manufacturer
BETTER LIVING BRANDS LLC. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2024-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:11:35

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure9 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

OTC - PURPOSE SECTION

Purpose

Acid reducer

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

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

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.

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

eso-minis-14s-labeleso-minis-14s-labeleso-minis-42s-ifceso-minis-42s-ifceso-minis-14s-ifceso-minis-14s-ifc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2

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
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
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
21130-257-41Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-257-41Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32
21130-257-45Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-257-45Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-257ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BETTER LIVING BRANDS LLC.]2Current NDC, 4 package rows20240429_f2c06861-0324-93ed-e053-2995a90a5902.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-25721130-257-45, 21130-257-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
TALC7SEV7J4R1UIACT
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OIACT
SUCROSEC151H8M554IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
FD&C RED NO. 3PN2ZH5LOQYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ESOMEPRAZOLE MAGNESIUMR6DXU4WAY9ACTIM
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
MAGNESIUM STEARATE70097M6I30IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
GELATIN2G86QN327LIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLYSORBATE 806OZP39ZG8HIACT

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
A217264-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29

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 22:38:342026-08A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-2984e616aacf4f…
2026-08-18 06:07:402026-07A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-298072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-299b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217264-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2023-09-29a50c72e98297…

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 MAGNESIUMBETTER LIVING BRANDS LLC.f2c06861-0324-93ed-e053-2995a90a59022024-04-20WarningsExact identifier
ndc (package): 21130-257-41
ndc (package): 21130-257-45
ndc (product): 21130-257
ndc11 (package): 21130025741
ndc11 (package): 21130025745
spl id: 16821d33-b446-b089-e063-6294a90ab73f
spl set id: f2c06861-0324-93ed-e053-2995a90a5902

Reported adverse events (FAERS/openFDA)#

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