Esomeprazole Magnesium

Manufacturer
The Kroger Co.
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:30:13

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientEsomeprazole Magnesium
Label structure12 sections

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 to 25°C (68 to 77°F)

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

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

Use(s)

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

Do not use

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)·
  • prescription ant fungal or anti-yeast medicines·
  • digoxin (heart medicine)·
  • diazepam (anxiety medicine)·
  • tacrolimus or mycophenolate mofetil (immune system medicines) ·
  • prescription antiretrovirals (medicines for HIV infection)·
  • methotrexate (arthritis medicine)

Stop use and ask 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.

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 to 25°C (68 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 7 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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

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
30142-55630142-556-14, 30142-556-28, 30142-556-42

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 · Source PDF

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
682d7ca8-cdb5-ad98-5f6f-7c7025bdbbcd2a2cd74d-be63-9bcb-8e80-ffc6739b79832021-05-13WarningsExact identifier
spl set id: 2a2cd74d-be63-9bcb-8e80-ffc6739b7983

Reported adverse events (FAERS/openFDA)#

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