omeprazole

Manufacturer
Rite Aid | Ohm Laboratories Inc.
Effective date
2022-03-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:36

Label at a glance#

Productomeprazole
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure7 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 1...

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, USP)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

  • treats frequent heartburn (occurs 2 or moredays 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

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 (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 Safety Information

■ 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 diglycerides, 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

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11822-0061-4
TREATS FREQUENT HEARTBURN
Compare to the active ingredient of Prilosec OTC®†

OMEPRAZOLE
Delayed-release Capsules 20 mg*
ACID REDUCER
Mini Cap 40% Smaller Capsule

24 HR

ACTUAL SIZE

42
CAPSULES
THREE 14-DAY COURSES OF TREATMENT
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
TRIPLE PACK 3 X 14 COUNT BOTTLE INSIDE

Principal Display Panel - 42 Capsule Bottle Carton
Principal Display Panel - 42 Capsule Bottle Carton

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

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
11822-0061-1omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
11822-0061-4omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0061OMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID]3Current NDC, Legacy NDC, 2 package rows20220305_b1ba65d1-8f68-4bae-bb9d-776bba348346.zip

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
11822-006111822-0061-1, 11822-0061-4

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
omeprazoleOMEPRAZOLERite Aidb1ba65d1-8f68-4bae-bb9d-776bba3483462022-03-03WarningsExact identifier
ndc (package): 11822-0061-1
ndc (package): 11822-0061-4
ndc (product): 11822-0061
ndc11 (package): 11822006104
ndc11 (package): 11822006101
spl id: 67c3cfe2-ab40-4c32-b386-ad3c740e3f6f
spl set id: b1ba65d1-8f68-4bae-bb9d-776bba348346

Reported adverse events (FAERS/openFDA)#

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