Nexium 24HR

Manufacturer
Haleon US Holdings LLC
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
monthly-update
Hydrated at
2026-06-03 17:52:35

Label at a glance#

ProductNexium 24HR
Active ingredientESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Label structure10 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 tablet)

Esomeprazole 20 mg

(Each delayed-release tablet 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

SPL UNCLASSIFIED SECTION

  • Do not use if you are allergic to esomeprazole
  • Esomeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash

If an allergic reaction occurs, stop use and seek medical attention 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

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.

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

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 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 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)
    1. you may repeat a 14-day course every 4 months
    2. 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

corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

Additional Information

SPL UNCLASSIFIED SECTION

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION”

or yellow band around the center of each capsule is broken or missing.

Tips for Managing Heartburn

  • Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty
  • and fried foods, chocolate, 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

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

©2022 GSK group of companies or its licensor

Made in France

For most recent product information, visit www.Nexium24HR.com

Nexium is a registered trademark of AstraZeneca AB and is used under license.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-2451-14

See new warning information

Treats Frequent Heartburn

Nexium®
24HR

esomeprazole magnesium

delayed-release tablets
20 mg/acid reducer

Tablets

May take 1 to 4 days for full effect

14
TABLETS

One 14-day course of treatment

000078388 Front Carton

Nexium 24 Hr Tablets 14ct
Nexium 24 Hr Tablets 14ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN12
1743279NexIUM 20 MG Delayed Release Oral TabletPSN12
1743279esomeprazole 20 MG Delayed Release Oral Tablet [Nexium]SBD12
433733esomeprazole 20 MG Delayed Release Oral TabletSCD12
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY12
1743279Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY12
1743279Nexium 20 MG Delayed Release Oral TabletSY12
1743279Nexium 24 HR 20 MG Delayed Release Oral TabletSY12

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2451-14Nexium 24HR1 in 1 CARTONTABLET112
0573-2451-14Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-28Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-28Nexium 24HR2 in 1 CARTONTABLET212
0573-2451-42Nexium 24HR3 in 1 BLISTER PACKTABLET312
0573-2451-42Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-43Nexium 24HR14 in 1 BOTTLETABLET1412
0573-2451-43Nexium 24HR3 in 1 PACKAGETABLET312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2451-14EA - Each0573-2451665a123b-947f-4789-b55e-a6ba8f01e73812016-04-04
0573-2451-42EA - Each0573-2451f4b1c017-209f-4f80-95a9-2a5a09c5487012016-04-04

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
0573-24510573-2451-14, 0573-2451-42, 0573-2451-28, 0573-2451-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112024-03-19full-release2026-06-01 00:10:02

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
N207920-001NEXIUM 24HRESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23c2088c7a36db…
2026-09-14 22:38:342026-08N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-2384e616aacf4f…
2026-08-18 06:07:402026-07N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-233f01610625f2…
2019-09-15 20:21 UTC2019-09N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207920-001NEXIUM 24HREQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2015-11-233a93d1ddd44b…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N207920-00164288102019-11-03U-1785Drug product2015-12-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207920-0016428810*PED2020-05-03Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N207920-0016428810*PED2020-05-03Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207920-0016428810*PED2020-05-03Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N207920-00164288102019-11-03U-1785Drug product2015-12-183f01610625f2…
2019-12-14 00:12 UTC2019-12N207920-0016428810*PED2020-05-03Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N207920-00164288102019-11-03U-1785Drug product2015-12-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N207920-0016428810*PED2020-05-03Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N207920-00164288102019-11-03U-1785Drug product2015-12-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N207920-0016428810*PED2020-05-03Pediatric extensionea99ee380514…

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
Nexium 24HRESOMEPRAZOLE MAGNESIUMHaleon US Holdings LLC61f67858-ba2f-449b-8b30-c15cdaf492222025-01-09WarningsExact identifier
ndc (package): 0573-2451-43
ndc (package): 0573-2451-28
ndc (package): 0573-2451-42
ndc (package): 0573-2451-14
ndc (product): 0573-2451
ndc11 (package): 00573245142
ndc11 (package): 00573245143
ndc11 (package): 00573245128
ndc11 (package): 00573245114
spl id: 9e3651ca-65ce-430f-9036-1f7e42629a79
spl set id: 61f67858-ba2f-449b-8b30-c15cdaf49222

Reported adverse events (FAERS/openFDA)#

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