FDA.reportPublic FDA data

Better Living Brands LLC Omeprazole Drug Facts

Manufacturer
Safeway
Effective date
2026-05-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:59:12

Label at a glance#

ProductOMEPRAZOLE
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure9 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...

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

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

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:

  • 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 help right away.

Do not use if you have:

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 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

If pregnant or breast-feeding,

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 (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
    1. swallow 1 capsule with a glass of water before eating in the morning
    2. take every day for 14 days
    3. do not take more than 1 capsule a day
    4. do not use for more than 14 days unless directed by your doctor
    5. swallow whole. Do not chew or crush capsules.
  • Repeated 14-Day Courses (if needed)
    1. you may repeat a 14-day course every 4 months
    2. 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

OTHER SAFETY 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
  • FDA approved dissolution test specifications differ from USP

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow # 6, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO Prilosec OTC® active ingredient

Signature SELECT™

OMEPRAZOLE

DELAYED RELEASE CAPSULES, 20 MG

ACID REDUCER | 24 HR

LOVE IT OR IT’S ON US

Treats FREQUENT Heartburn!

Actual Size

MINI CAPSULES

42 CAPSULES

See current Drug Facts

Three 14-day courses of treatment

May take 1 to 4 days for full effect

signature-select-omeprazole-carton-image-1.jpg
signature-select-omeprazole-carton-image-1.jpg
signature-select-omeprazole-carton-image-2.jpg
signature-select-omeprazole-carton-image-2.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codealbtsn.com/ugtgka2signature-select-omeprazole-carton-image-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-783-01OMEPRAZOLE1 in 1 CARTONCAPSULE, DELAYED RELEASE13
21130-783-01OMEPRAZOLE14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
21130-783-03OMEPRAZOLE3 in 1 CARTONCAPSULE, DELAYED RELEASE33
21130-783-03OMEPRAZOLE14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-78321130-783-03, 21130-783-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OMEPRAZOLE MAGNESIUM426QFE7XLKACTIM
FD&C YELLOW NO. 6H77VEI93A8IACT
FERRIC OXIDE RED1K09F3G675IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MEGLUMINE6HG8UB2MUYIACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
SHELLAC46N107B71OIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-04-27weekly-update2026-06-03 18:02:29

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
A216096-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-2484e616aacf4f…
2026-08-18 06:07:402026-07A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-245c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24a50c72e98297…

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
OMEPRAZOLEOMEPRAZOLESafewayb3ec4a44-5643-4438-b41b-e049464367192026-05-18WarningsExact identifier
ndc (package): 21130-783-03
ndc (package): 21130-783-01
ndc (product): 21130-783
ndc11 (package): 21130078301
ndc11 (package): 21130078303
spl id: ba9d8915-89e0-4a90-a8e3-03784b496950
spl set id: b3ec4a44-5643-4438-b41b-e04946436719

Reported adverse events (FAERS/openFDA)#

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