Esomeprazole Magnesium Delayed-Release Capsules 20 mg - Actavis

Manufacturer
P & L Development, LLC
Effective date
2024-11-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:32:56

Label at a glance#

ProductAcid Reducer
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure16 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 c...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Esomeprazole 20 mg
(*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (trihydrate))

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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

black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid - ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono-and di-glycerides, polyethylene glycol, polysorbate 80, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, sodium stearyl fumarate, sugar spheres (corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Nexium® 24 Hour †

see new warning information

24-hour

esomeprazole magnesium

delayed-release tablets, 20 mg*

acid reducer

treats frequent heartburn

may take 1 to 4 days for full effect

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Nexium® 24HR.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP IS BROKEN OR MISSING.

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

READYinCASE Esomeprazole Magnesium Delayed-Release Tablets, 20 mg
READYinCASE Esomeprazole Magnesium Delayed-Release Tablets, 20 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN4
433733esomeprazole 20 MG Delayed Release Oral TabletSCD4
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY4

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
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
59726-056-14Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE144
59726-056-14Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE14
59726-056-42Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE34
59726-056-42Acid Reducer14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-056ACID REDUCER (ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [P & L DEVELOPMENT, LLC]4Legacy NDC, 4 package rows20241103_08f09939-10d1-4380-81bb-826856444674.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-05659726-056-14, 59726-056-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
A212088-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25

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 22:38:342026-08A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2584e616aacf4f…
2026-08-18 06:07:402026-07A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25a50c72e98297…

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
03fda90d-5e9e-4340-899b-0e3734510a6608f09939-10d1-4380-81bb-8268564446742024-11-01WarningsExact identifier
spl id: 03fda90d-5e9e-4340-899b-0e3734510a66
spl set id: 08f09939-10d1-4380-81bb-826856444674

Reported adverse events (FAERS/openFDA)#

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