Esomeprazole Magnesium 20mg - Cabinet Health P.B.C.
- Manufacturer
- Cabinet Health P.B.C.
- Effective date
- 2026-08-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-08-18 02:02:07
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP)
OTC - PURPOSE SECTION
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 may include:
skin reddening
blisters
rash
If an allergic reaction occurs, stop use and seek
medical help 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 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° to 25°C (68° to 77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
ammonia, black iron oxide, corn starch, dimethicone, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate.
OTC - QUESTIONS SECTION
Questions or comments?
Call
1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM
EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Primary Display Panel
Products#
Every source-derived product name is available through these pages.
- GoodMeds Acid Reducer 24HR Esomeprazole Magnesium Delayed-Release 20mg
- Esomeprazole Magnesium 20mg
- ESOMEPRAZOLE MAGNESIUM
- ESOMEPRAZOLE
- STARCH, CORN
- HYPROMELLOSE 2910 (5 MPA.S)
- TITANIUM DIOXIDE
- TALC
- TRIETHYL CITRATE
- FERROSOFERRIC OXIDE
- FD&C BLUE NO. 1
- FD&C BLUE NO. 2
- GELATIN
- GLYCERYL MONOSTEARATE
- MAGNESIUM STEARATE
- POTASSIUM HYDROXIDE
- POLYSORBATE 80
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM LAURYL SULFATE
- SUCROSE
- HYDROXYPROPYL CELLULOSE (1600000 WAMW)
- AMMONIA
- DIMETHICONE
- METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82725-4053 | 82725-4053-1 |
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 |
|---|---|---|---|---|---|---|---|
| A212507-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 |
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 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212507-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2020-06-02 | 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 |
|---|---|---|---|---|---|---|
| GoodMeds Acid Reducer 24HR Esomeprazole Magnesium Delayed-Release 20mg | ESOMEPRAZOLE MAGNESIUM 20MG | Cabinet Health P.B.C. | 58cbd617-cff5-ad52-e063-6394a90a7247 | 2026-08-11 | Warnings | 82725-4053-1 82725-4053 82725405301 58cbd617-cff6-ad52-e063-6394a90a7247 58cbd617-cff5-ad52-e063-6394a90a7247 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
