Omeprazole Delayed-Release Tablets, 20 mg/acid reducer

Manufacturer
Camber Consumer Care Inc | Hetero Labs Limited Unit III
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:51:54

Label at a glance#

ProductOmeprazole
Active ingredientOMEPRAZOLE
Label structure15 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 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 14 days unless directed by your doctor •  swa...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole delayed-release tablet, 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:
Do not use if you are allergic to omeprazole.
• Omeprazole may cause severe skin reactions. Symptoms may include:
   • skin reddening • blisters • rash
If an allergy 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.

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 tablet with a glass of water before eating in the morning
• take every day for 14 days
• do not take 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 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) and protect from moisture


Inactive ingredients

INACTIVE INGREDIENT SECTION


colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Questions?

SPL UNCLASSIFIED SECTION

1-888-588-1418

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

NDC 69230-318-35

See Current Drug Facts

Compare to Prilosec OTC ®*

Omeprazole
Delayed-Release Tablets
20 mg

Acid Reducer

Treats FREQUENT Heartburn!
Occuring 2 Or More Days A Week

24 HR

One 14-day course of treatment
May take 1 to 4 days for full effect

14 TABLETS

omeprazoledelayedreleasetablets14countcontainercarton
omeprazoledelayedreleasetablets14countcontainercarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN5
402014omeprazole 20 MG Delayed Release Oral TabletSCD5
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY5

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
69230-318-05Omeprazole500 in 1 BOTTLETABLET, DELAYED RELEASE5005
69230-318-10Omeprazole1000 in 1 BOTTLETABLET, DELAYED RELEASE10005
69230-318-32Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
69230-318-32Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69230-318-33Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
69230-318-33Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69230-318-34Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
69230-318-34Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69230-318-35Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
69230-318-35Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
69230-318-36Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
69230-318-36Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
69230-318-37Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
69230-318-37Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-318OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [CAMBER CONSUMER CARE INC]5Current NDC, Legacy NDC, 14 package rows20221129_9c856d3a-e38f-4006-a43a-ec1a9fa0f057.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-318-31EA - Each69230-3184a57d6cd-427e-4cad-8365-1e23dd5f380e12021-04-08
69230-318-35EA - Each69230-318006859ef-5ea8-45d9-8819-bf69c254401312021-04-08
69230-318-36EA - Each69230-318f09f87a8-decb-4440-a2f4-1b186aa9a13612021-04-08
69230-318-37EA - Each69230-3187205699e-0a21-476d-af84-77ad10f875be12021-04-08

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
A211732-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25

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 22:38:342026-08A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2584e616aacf4f…
2026-08-18 06:07:402026-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25a50c72e98297…

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
OmeprazoleOMEPRAZOLECamber Consumer Care Inc9c856d3a-e38f-4006-a43a-ec1a9fa0f0572022-11-28WarningsExact identifier
ndc (package): 69230-318-35
ndc (package): 69230-318-36
ndc (package): 69230-318-33
ndc (package): 69230-318-32
ndc (package): 69230-318-37
ndc (package): 69230-318-34
ndc (package): 69230-318-05
ndc (package): 69230-318-10
ndc (product): 69230-318
ndc11 (package): 69230031836
ndc11 (package): 69230031833
ndc11 (package): 69230031834
ndc11 (package): 69230031805
ndc11 (package): 69230031832
ndc11 (package): 69230031810
ndc11 (package): 69230031837
ndc11 (package): 69230031835
spl id: ee873df8-2b35-9bc7-e053-2a95a90a0f83
spl set id: 9c856d3a-e38f-4006-a43a-ec1a9fa0f057

Reported adverse events (FAERS/openFDA)#

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