FDA.reportPublic FDA data

731R HEB Omeprazole Delayed-Release Tablets 20 mg

Manufacturer
H-E-B | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-04-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:41:42

Label at a glance#

ProductOmeprazole Delayed-Release
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Omeprazole, USP 20 mg

(equivalent to 20.6 mg omeprazole magnesium)

OTC - PURPOSE SECTION

Purpose

Acid reducer

INDICATIONS & USAGE SECTION

Use

  • 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 omeprazole.
  • Omeprazole may cause severe skin reactions. Symptoms may 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

  • for adults 18 years of age and older
  • this product is to be used once a day (every 24 hours), every day for 14 days
  • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew or crush tablets.

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. 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) and protect from moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients

colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

731R HEB 14ct label

731R HEB 14ct label731R HEB 14ct label

731R HEB 14ct carton

731R HEB 14ct carton731R HEB 14ct carton

731R HEB 28ct carton

731R HEB 28ct carton731R HEB 28ct carton

731R HEB 42ct carton

731R HEB 42ct carton731R HEB 42ct carton

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-56937808-569-45, 37808-569-82, 37808-569-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYSORBATE 806OZP39ZG8HIACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUCROSEC151H8M554IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TALC7SEV7J4R1UIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
OMEPRAZOLE MAGNESIUM426QFE7XLKACTIM

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
A218829-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07

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
2026-09-14 22:38:342026-08A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-0784e616aacf4f…
2026-08-18 06:07:402026-07A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07a50c72e98297…

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
Omeprazole Delayed-ReleaseOMEPRAZOLEH-E-B448ba584-6a6e-3d85-e063-6294a90a55792026-04-29WarningsExact identifier
ndc (package): 37808-569-45
ndc (package): 37808-569-82
ndc (package): 37808-569-41
ndc (product): 37808-569
ndc11 (package): 37808056945
ndc11 (package): 37808056941
ndc11 (package): 37808056982
spl id: 50962214-2053-1974-e063-6394a90a0fc0
spl set id: 448ba584-6a6e-3d85-e063-6294a90a5579

Reported adverse events (FAERS/openFDA)#

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