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)
Nexium 24HR
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2018-04-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:59:51
Label at a glance#
ProductNexium 24HR
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure10 sections
Contacts and useful links#
Websitewww.nexium24hr.com
www.Nexium24HR.com
www.Nexium24HR.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredient (in each capsule) | Purpose |
|---|---|
| (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate) | |
| Esomeprazole 20 mg | 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
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 signs of a serious condition. See your doctor.
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, 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
- warfarin, clopidogrel or cilostazol (blood-thinning medicines)
- prescription antifungal or anti-yeast medicines
- digoxin (heart medicine)
- diazepam (anxiety medicine)
- tacrolimus or mycophenolate mofetil (immune system medicines)
- prescription antiretrovirals (medicines for HIV infection)
- methotrexate (arthritis medicine)
Stop use and ask a doctor if
- 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 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
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
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
Made in France
For most recent product information, visit www.Nexium24HR.com
HOW SUPPLIED
Product: 50090-1461
NDC: 50090-1461-0 14 CAPSULE, DELAYED RELEASE in a BOTTLE / 1 in a CARTON
esomeprazole magnesium
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 654900099876541299 | lbl500901461.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-2450-14 | EA - Each | 0573-2450 | b1dd1d1e-cc3d-4bc3-a4f8-ca291490ef74 | 1 | 2014-06-03 |
| 0573-2450-15 | EA - Each | 0573-2450 | 6b7357ba-9d45-43d2-8d27-5d06c4aa0913 | 1 | 2015-07-20 |
| 0573-2450-28 | EA - Each | 0573-2450 | 1103a115-63d5-45d7-8ebc-0b397421929a | 1 | 2014-06-03 |
| 0573-2450-42 | EA - Each | 0573-2450 | aa4a4eb6-79d1-481a-9b2d-187f0499b358 | 1 | 2014-07-02 |
| 0573-2450-43 | EA - Each | 0573-2450 | 834bdac9-a121-4729-81c0-bebc94327edd | 1 | 2014-07-02 |
| 0573-2450-56 | EA - Each | 0573-2450 | 79d2f892-8ffd-4a87-9bc5-032d0d2bc1ef | 1 | 2015-10-02 |
Products#
Every source-derived product name is available through these pages.
- Nexium 24HR
- esomeprazole magnesium
- ESOMEPRAZOLE
- STARCH, CORN
- D&C RED NO. 28
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FERRIC OXIDE RED
- GELATIN, UNSPECIFIED
- GLYCERYL MONOSTEARATE
- HYDROXYPROPYL CELLULOSE (1200000 MW)
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
- POLYSORBATE 80
- SUCROSE
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-1461 | 50090-1461-0 |
| 0573-2450 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204655-001 | NEXIUM 24HR | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N204655-001 | NEXIUM 24HR | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | RLD, RS | 2014-03-28 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N204655-001 | 6428810 | 2019-11-03 | U-1874 | Drug product | 2014-04-24 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N204655-001 | 6428810 | 2019-11-03 | U-1509 | Drug product | 2014-04-24 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N204655-001 | 6428810*PED | 2020-05-03 | Pediatric extension | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N204655-001 | 6428810*PED | 2020-05-03 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N204655-001 | 6428810*PED | 2020-05-03 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N204655-001 | 6428810 | 2019-11-03 | U-1874 | Drug product | 2014-04-24 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N204655-001 | 6428810 | 2019-11-03 | U-1509 | Drug product | 2014-04-24 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N204655-001 | 6428810*PED | 2020-05-03 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N204655-001 | 6428810 | 2019-11-03 | U-1874 | Drug product | 2014-04-24 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N204655-001 | 6428810 | 2019-11-03 | U-1509 | Drug product | 2014-04-24 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N204655-001 | 6428810*PED | 2020-05-03 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N204655-001 | 6428810 | 2019-11-03 | U-1874 | Drug product | 2014-04-24 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N204655-001 | 6428810 | 2019-11-03 | U-1509 | Drug product | 2014-04-24 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N204655-001 | 6428810*PED | 2020-05-03 | Pediatric extension | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nexium 24HR | ESOMEPRAZOLE MAGNESIUM | Haleon US Holdings LLC | 4513934d-0cf0-40fc-a348-b4e75a33b094 | 2024-03-19 | Warnings | 0573-2450 |
| 9494990a-afce-41c6-9f3a-061e23b4174a | 4a9fe897-db08-4e14-b243-d2124a07d1d1 | 2018-04-18 | Warnings | 9494990a-afce-41c6-9f3a-061e23b4174a 4a9fe897-db08-4e14-b243-d2124a07d1d1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.