Omeprazole

Manufacturer
Little Pharma, Inc.
Effective date
2022-07-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:55:59

Label at a glance#

ProductOmeprazole
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure11 sections

Dosage and administration

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 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 do not use for more than 14 days unless ...

Storage and handling

read the directions and warnings before use. keep the carton. It contains important information. Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

*Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

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

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to omeprazole

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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
    • do not use for more than 14 days unless directed by your doctor
    • swallow whole. Do not chew or crush capsules.

    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 information

STORAGE AND HANDLING SECTION

  • read the directions and warnings before use.
  • keep the carton. It contains important information.
  • Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

Questions?

OTC - QUESTIONS SECTION

Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984.

SPL UNCLASSIFIED SECTION

Distributed by:
Little Pharma, Inc.
New York, NY 10023

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

curist

Heartburn Relief

Omeprazole Delayed-release Capsules 20 mg*
Acid Reducer

24 HR; Treats FREQUENT Heartburn!

42 CAPSULES
Three 14-day courses of treatment
May take 1 to 4 days for full effect

mini capsules

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Carton
PRINCIPAL DISPLAY PANEL - 20 mg Capsule 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
72559-01072559-010-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
A210593-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-2084e616aacf4f…
2026-08-18 06:07:402026-07A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-203f01610625f2…
2019-09-15 20:21 UTC2019-09A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210593-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-07-20f41ea6bd6efb…

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
263221d8-3de9-fa56-e063-6294a90adaa5e7a9bd1c-9d47-4c2b-9373-b8f2139c52072024-11-05WarningsExact identifier
spl set id: e7a9bd1c-9d47-4c2b-9373-b8f2139c5207

Reported adverse events (FAERS/openFDA)#

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