Esomeprazole magnesium
- Manufacturer
- BETTER LIVING BRANDS, LLC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2023-11-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:26
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each capsule)
Esomeprazole 20 mg
(Each delayed-release capsule 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
- 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.
OTC - DO NOT USE SECTION
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.
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, 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.
OTC - STOP USE SECTION
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 (1-800-222-1222) 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
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 SAFETY INFORMATION
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 black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.
OTC - QUESTIONS SECTION
Questions or comments?1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 4 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 4 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 4 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ESOMEPRAZOLE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 8 | 20171212 |
| 094c6751-235c-4d12-acee-2baf94f676f4 | Product name | 1 | 20151116 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21130-718-41 | Esomeprazole magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 4 | |
| 21130-718-41 | Esomeprazole magnesium | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | 4 | |
| 21130-718-45 | Esomeprazole magnesium | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | 4 | |
| 21130-718-45 | Esomeprazole magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | 4 | |
| 21130-718-82 | Esomeprazole magnesium | 14 in 1 CARTON | CAPSULE, DELAYED RELEASE | 14 | 4 | |
| 21130-718-82 | Esomeprazole magnesium | 2 in 1 CARTON | CAPSULE, DELAYED RELEASE | 2 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Esomeprazole magnesium
- DIMETHICONE
- FERROSOFERRIC OXIDE
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
- HYPROMELLOSES
- POTASSIUM HYDROXIDE
- FD&C BLUE NO. 1
- GELATIN
- GLYCERYL MONOSTEARATE
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- POLYSORBATE 80
- SHELLAC
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
- FD&C RED NO. 3
- FERRIC OXIDE YELLOW
- MAGNESIUM STEARATE
- SUCROSE
- ESOMEPRAZOLE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21130-718 | 21130-718-45, 21130-718-41, 21130-718-82 |
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 |
|---|---|---|---|---|---|---|---|
| A217264-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 |
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 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217264-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2023-09-29 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Esomeprazole magnesium | ESOMEPRAZOLE MAGNESIUM | BETTER LIVING BRANDS, LLC | eb4c1cac-89a2-c040-e053-2995a90ae1cd | 2023-11-17 | Warnings | 21130-718-45 21130-718-41 21130-718-82 21130-718 21130071882 21130071845 21130071841 0a55d8b3-0539-2e0d-e063-6294a90a92a4 eb4c1cac-89a2-c040-e053-2995a90ae1cd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



