Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Manufacturer
Rising Pharma Holdings, Inc. | Graviti Pharmaceuticals Private Limited
Effective date
2026-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:36:00

Label at a glance#

ProductESOMEPRAZOLE MAGNESIUM
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure2 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Active ingredient (in each capsule)
Purpose
Esomeprazole 20 mg
Acid reducer
(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

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:

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 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

  • 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

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 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 Ingredients

FD&C Blue No.2, gelatin, hypromellose, hydroxy propyl cellulose, magnesium stearate, methacrylic acid & ethyl acrylate copolymer dispersion, mono and di glycerides, pharmaceutical ink, polysorbate 80, sugar spheres, talc, triethyl citrate.

Questions or comments?

Call 1-844-474-7464

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

Manufactured by:

Graviti Pharnaceuticals Pvt. Ltd.

Telangana-502307, INDIA.

M.L.No.: 12/SRD/TS/2017/F/G

Revised: 04/2026

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 20 mg Capsules: Container Label

NDC 64980-664-41

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 Capsules

One 14-day course of treatment

Distributed by: Rising Pharma Holdings, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 20 mg Capsules: Carton Label

NDC 64980-664-41

Compare to the active ingredient in Nexium®24HR"

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 Capsules

One 14-day course of treatment

Distributed by: Rising Pharma Holdings, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
IMG
IMG

Principal Display Panel - 20 mg Capsules: Carton Label

NDC 64980-664-19

Compare to the active ingredient in Nexium® 24HR"

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

42 Capsules

Three 14-day courses of treatment

Distributed by: Rising Pharma Holdings, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
IMG
IMG

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130364980664196GTIN-13: 0364980664196
EAN-13: 0364980664196
GTIN-12: 364980664196
UPC-A: 364980664196
GTIN storage (14 digits): 00364980664196
b0715b2b-3453-4088-891d-91a1aa22f57d-04.jpg
BarcodeEAN-130364980664417GTIN-13: 0364980664417
EAN-13: 0364980664417
GTIN-12: 364980664417
UPC-A: 364980664417
GTIN storage (14 digits): 00364980664417
b0715b2b-3453-4088-891d-91a1aa22f57d-02.jpg

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64980-66464980-664-41, 64980-664-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
A216349-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24

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
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2026-02-19 14:30 UTC2026-02A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24011fe1cb6892…
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2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-248072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-241c564ffb4f44…
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2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216349-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-06-24a50c72e98297…

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
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.2164e1d7-e601-4ce5-be29-0c21c3a5a6472026-04-16Exact identifier
ndc (package): 64980-664-19
ndc (package): 64980-664-41
ndc (product): 64980-664
ndc11 (package): 64980066419
ndc11 (package): 64980066441
spl id: b0715b2b-3453-4088-891d-91a1aa22f57d
spl set id: 2164e1d7-e601-4ce5-be29-0c21c3a5a647

Reported adverse events (FAERS/openFDA)#

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