Nexium 24HR

Manufacturer
A-S Medication Solutions
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
legacy-cache
Hydrated at
2026-08-01 21:02:35

Label at a glance#

ProductNexium 24HR
Active ingredientESOMEPRAZOLE MAGNESIUM
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#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg

esomeprazole magnesium trihydrate)

Purpose

OTC - PURPOSE SECTION

Acid reducer

INDICATIONS & USAGE SECTION

Uses

  • treats frequent heartburn (occurs 2 or moredays 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

  1. Ask a doctor or pharmacist before use if you are
  2. 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 Repeated 14-Day Courses (if needed)
    • 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
    • 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.

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 (Nexium 24HR Capsules)

corn starch, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

Inactive Ingredients (Nexium 24HR ClearMinis)

carmine, corn starch, FD&C blue no. 2, FD&C blue no. 2 aluminum lake, FD&C red no. 3, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, 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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1460

NDC: 50090-1460-0 14 CAPSULE, DELAYED RELEASE in a BOTTLE / 2 in a CARTON

esomeprazole magnesium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1460-02023-02-07C16284748780-1f386c64a-36c3-0266-e053-dadaa90a7c1aDrug Facts
50090-1460-02023-01-30C16284748780-1f386c64a-36c3-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1460NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]17Legacy NDC20240516_477cfda2-44cf-4d0e-bdc4-e30bf16bfea9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1460-0EA - Each50090-146069ed630c-90cc-4a73-aea3-fa68eec343cf12018-08-13
0573-2450-14EA - Each0573-2450b1dd1d1e-cc3d-4bc3-a4f8-ca291490ef7412014-06-03
0573-2450-15EA - Each0573-24506b7357ba-9d45-43d2-8d27-5d06c4aa091312015-07-20
0573-2450-28EA - Each0573-24501103a115-63d5-45d7-8ebc-0b397421929a12014-06-03
0573-2450-42EA - Each0573-2450aa4a4eb6-79d1-481a-9b2d-187f0499b35812014-07-02
0573-2450-43EA - Each0573-2450834bdac9-a121-4729-81c0-bebc94327edd12014-07-02
0573-2450-56EA - Each0573-245079d2f892-8ffd-4a87-9bc5-032d0d2bc1ef12015-10-02

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-146050090-1460-0
0573-2450

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

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
N204655-001NEXIUM 24HRESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28

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 22:38:342026-08N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2884e616aacf4f…
2026-08-18 06:07:402026-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N204655-00164288102019-11-03U-1874Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204655-00164288102019-11-03U-1509Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204655-0016428810*PED2020-05-03Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N204655-0016428810*PED2020-05-03Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204655-0016428810*PED2020-05-03Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N204655-00164288102019-11-03U-1874Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N204655-00164288102019-11-03U-1509Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N204655-0016428810*PED2020-05-03Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N204655-00164288102019-11-03U-1874Drug product2014-04-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N204655-00164288102019-11-03U-1509Drug product2014-04-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N204655-0016428810*PED2020-05-03Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N204655-00164288102019-11-03U-1874Drug product2014-04-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N204655-00164288102019-11-03U-1509Drug product2014-04-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N204655-0016428810*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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
06ed1986-6604-49cb-82bf-4528bd81bcbb477cfda2-44cf-4d0e-bdc4-e30bf16bfea92025-08-18WarningsExact identifier
spl set id: 477cfda2-44cf-4d0e-bdc4-e30bf16bfea9
Nexium 24HRESOMEPRAZOLE MAGNESIUMHaleon US Holdings LLC4513934d-0cf0-40fc-a348-b4e75a33b0942024-03-19WarningsExact identifier
ndc (product): 0573-2450

Reported adverse events (FAERS/openFDA)#

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