Gericare Esompeprazole Magnesium Delayed-Release Capsules USP, 20 mg* / Acid Reducer

Manufacturer
GERI-CARE PHARMACEUTICALS, CORP | Ohm Laboratories Inc.
Effective date
2026-06-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-03 03:02:22

Label at a glance#

ProductEsomeprazole
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure15 sections

Dosage and administration

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 docto...

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 help right away.

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:

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 information

OTHER SAFETY INFORMATION

  • read the directions and warnings before use
  • Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
  • keep the carton. It contains important information.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-540-3765 weekdays.

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around 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.

SPL UNCLASSIFIED SECTION

Distributed by:
GERI-CARE PHARMACEUTICALS CORP.
1295 Towbin Avenue
Lakewood, NJ 08701
REV 0326

PRINCIPAL DISPLAY PANEL - 42 count Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357896740429GTIN-13: 0357896740429
EAN-13: 0357896740429
GTIN-12: 357896740429
UPC-A: 357896740429
GTIN storage (14 digits): 00357896740429
Gericare Esomeprazole DR Cap 42ct Carton 5269694.jpg
Data codeITF05269694Gericare Esomeprazole DR Cap 42ct Carton 5269694.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-74057896-740-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 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
A212866-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04c2088c7a36db…
2026-09-14 22:38:342026-08A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-0484e616aacf4f…
2026-08-18 06:07:402026-07A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212866-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2020-05-04a50c72e98297…

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
EsomeprazoleESOMEPRAZOLE MAGNESIUMGERI-CARE PHARMACEUTICALS, CORP53a21928-8f5b-52c1-e063-6294a90add6c2026-06-06WarningsExact identifier
ndc (package): 57896-740-42
ndc (product): 57896-740
ndc11 (package): 57896074042
spl id: 53a17381-d2f1-143f-e063-6394a90a07a6
spl set id: 53a21928-8f5b-52c1-e063-6294a90add6c

Reported adverse events (FAERS/openFDA)#

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