Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg*

Manufacturer
Amerisource Bergen | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2023-01-13
Label type
Human OTC Drug Label
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:40:30

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientESOMEPRAZOLE MAGNESIUM DIHYDRATE
Label structure15 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 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 d...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient   (in each capsule) 


*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate 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

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, 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 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 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.

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
  • Meets USP dissolution test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.

Questions or comments?


call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


Distributed By Amerisource Bergn
1300 Morris Drive, Chesterbrook, PA 19087
Questions or Concerns?       
www.mygnp.com

Made in India
Code: TS/DRUGS/22/2009


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx
GOOD                         NDC 46122-538-74                        
NEIGHBOR                                      
PHARMACY®
                                      
                                                        24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn         Capsules
May take 1 to 4 days for full effect    
14 Capsules  |one 14-day course  of treatment

esomeprazole-fig1.jpgesomeprazole-fig1.jpg


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx
GOOD                                                Compare to Nexium® 24 HR
NEIGHBOR                                       active ingredient**
PHARMACY®
                                  NDC 46122-538-74
See new warning information                24 HR
Esomeprazole
Magnesium

delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect           actual
14                    Capsules                         size
Capsules
 |     one 14-day course
                        of treatment



esomeprazole-fig2.jpg
esomeprazole-fig2.jpg

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsule Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx
GOOD
NEIGHBOR                                  Compare to Nexium® 24 HR  active ingredient**
PHARMACY®                               NDC 46122-538-03
See new warning information              24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect     Capsules      actual
                                                                                size
28 Capsules | two 14-day courses
(2 bottles of 14 each) | of treatment

esomeprazole-fig3.jpgesomeprazole-fig3.jpg



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsule Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx
GOOD
NEIGHBOR             Compare to Nexium® 24 HR  active ingredient**
PHARMACY®         NDC 46122-538-04
See new warning information              24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect     Capsules      actual
                                                                                  size
42 Capsules                | three 14-day courses of treatment
(3 bottles of 14 each)

esomeprazole-fig4.jpgesomeprazole-fig4.jpg


DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-538-03EA - Each46122-538efb7fe4e-44fd-4a07-a684-e0c6d323d28f12019-02-13
46122-538-04EA - Each46122-538d5747af4-abcd-4073-96d8-0ee2d3aaa5bc12019-02-13
46122-538-74EA - Each46122-53890fda73f-82fa-4c6e-af8f-5722e24f6a3012019-02-13

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-53846122-538-74, 46122-538-03, 46122-538-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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 44.

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
A209339-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-16

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 · 44 observed states.

Captured, Edition, Application-product table
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2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-168072bd15b7f6…
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2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-163f0d92c62455…
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2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209339-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-10-163a93d1ddd44b…

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6919f6f4-9f1a-4c3c-ac91-589881a6ceb5883c6967-9b25-41cc-af53-526a0517bfb42023-01-13WarningsExact identifier
spl id: 6919f6f4-9f1a-4c3c-ac91-589881a6ceb5
spl set id: 883c6967-9b25-41cc-af53-526a0517bfb4

Reported adverse events (FAERS/openFDA)#

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