FDA.reportPublic FDA data

464 - ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Manufacturer
Allegiant Health
Effective date
2024-07-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:57:29

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure9 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 Repeated 14-Day Courses (if needed) 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 1...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use(s)

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • 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.

Do not use

OTC - DO NOT USE SECTION

  • 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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

you are 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

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 Repeated 14-Day Courses (if needed)

  • 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.

Other information

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

FD&C Blue 2, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion, Mono-and Di-Glycerides, Pharmaceutical Ink, Polysorbate 80, Sugar Spheres, Talc, Triethyl Citrate.

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esomeprazole Magnesium Delayed-Release Capsule USP, 20mg 24HREsomeprazole Magnesium Delayed-Release Capsule USP, 20mg 24HREsomeprazole Magnesium Delayed-Release Capsule USP, 20mg 24HREsomeprazole Magnesium Delayed-Release Capsule USP, 20mg 24HR

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
69168-46469168-464-14, 69168-464-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ESOMEPRAZOLE MAGNESIUMR6DXU4WAY9ACTIM
FD&C BLUE NO. 2L06K8R7DQKIACT
GELATIN2G86QN327LIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL DISTEARATE73071MW2KMIACT
POLYSORBATE 806OZP39ZG8HIACT
RAW SUGAR8M707QY5GHIACT
TALC7SEV7J4R1UIACT
TRIETHYL CITRATE8Z96QXD6UMIACT

Source Document#

Source XML

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
ed7a257a-b262-4e9b-9162-821e8ebca8dd5ef433d4-b60a-4147-a0c0-ccdbf3204afc2024-07-29WarningsExact identifier
spl set id: 5ef433d4-b60a-4147-a0c0-ccdbf3204afc

Reported adverse events (FAERS/openFDA)#

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