Reliable-1 Esomeprazole Magnesium DR Capsules

Manufacturer
Reliable 1 Laboratories
Effective date
2021-08-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:50

Label at a glance#

ProductEsomeprazole
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure14 sections

Indications and uses

treats frequent heartburn (occurs 2 or more days a week) not intended for innediate 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 prodcut is to be used once a day (every 24 hours), every day for 14 days make 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 of more than 14 days unless directed by your docto...

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

treats frequent heartburn (occurs 2 or more days a week)

not intended for innediate 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 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 sings 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, particulary 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

warfarin, clopifogrel or cilostazol (blood-thinning medicines)

prescription antifungal or anti-yeast medications

digozin (heart medicine)

diazepam (anxiety medicine)

tacrolimus or mycophenolate mofetil (immune system medicines)

prescription antiretovirals (medicines for HIV infections)

methotrexate (arthritis medicine)

OTC - STOP USE SECTION

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this prodcut 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 prefessional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contract a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults 18 years of age and older

this prodcut is to be used once a day (every 24 hours), every day for 14 days

make 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 of more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

you may repeart a 14-day course every 4 months

do not take for more than 14 days or more often than every 4 mounths unless directed by a doctor

children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be cuased by a serious condition.

Other Information

OTHER SAFETY INFORMATION

each capsule contains: magnesium, 15 mg

read the directions and warmings before use

keep the carton. It contains important information.

store at 20-25ºC (68 to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium odixe, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call tool-free weekdays 8 AM to 10 PM EST at 1-888-375-3784

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-056-42

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

Esomeprazole Magnesium

Delayed-Release Capsules, USP

20 mg*

Acid Reducer

42 Capsules

Three 14-day Courses of Treatment

EsomeprazoleEsomeprazole

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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-056-14Esomeprazole14 in 1 BOTTLE, PLASTICCAPSULE142
69618-056-42Esomeprazole3 in 1 CARTONCAPSULE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-056ESOMEPRAZOLE CAPSULE [RELIABLE 1 LABORATORIES]2Legacy NDC, 2 package rows20210810_7a7b80f1-fd8a-a78f-e053-2991aa0a7098.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-056-14EA - Each69618-0566ff2d3b4-243d-41a7-b1d5-7391cc69cfea12019-01-24
69618-056-42EA - Each69618-056fae021f5-ade7-42ec-836a-1a04495216e912019-01-24

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-05669618-056-14, 69618-056-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
A207673-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1584e616aacf4f…
2026-08-18 06:07:402026-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15f41ea6bd6efb…

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
c928000b-a4cf-6fb0-e053-2995a90a7eef7a7b80f1-fd8a-a78f-e053-2991aa0a70982021-08-09WarningsExact identifier
spl id: c928000b-a4cf-6fb0-e053-2995a90a7eef
spl set id: 7a7b80f1-fd8a-a78f-e053-2991aa0a7098

Reported adverse events (FAERS/openFDA)#

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