Omeprazole

Manufacturer: Walgreen Company | Ohm Laboratories Inc. | Srini Pharmaceuticals Private Limited
Effective date: 2021-12-03
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:45:26

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1800-406-7984

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

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

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.

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

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

DIST. BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD,
IL 60015

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-9980-14

Walgreens

Compare to active ingredient in
Prilosec OTC^®††

Walgreens
PHARMACIST RECOMMENDED

Omeprazole

DELAYED-RELEASE CAPSULES 20 mg* / ACID REDUCER

24HR

• Treats frequent heartburn

14
CAPSULES

FOR FULL EFFECT

ACTUAL SIZE

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	3
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OMEPRAZOLE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-9980-14	Omeprazole	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	3
0363-9980-14	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	3
0363-9980-28	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	3
0363-9980-28	Omeprazole	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	3
0363-9980-42	Omeprazole	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	3
0363-9980-42	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9980	OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]	3	Current NDC, Legacy NDC, 6 package rows	20211207_537b9a46-ecc8-4537-9657-c9ff7821dd4b.zip

Products#

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

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

Omeprazole
OMEPRAZOLE MAGNESIUM
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (70000 WAMW)
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM CARBONATE
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYSORBATE 80
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
STARCH, CORN
SUCROSE
FD&C BLUE NO. 1
FD&C RED NO. 40
POLYETHYLENE GLYCOL 6000

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-9980	0363-9980-42, 0363-9980-28, 0363-9980-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OMEPRAZOLE MAGNESIUM	426QFE7XLK	ACTIM
FERROSOFERRIC OXIDE	XM0M87F357	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)	66O7AQV0RT	IACT
HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	IACT
MAGNESIUM CARBONATE	0E53J927NA	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER	NX76LV5T8J	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
STARCH, CORN	O8232NY3SJ	IACT
SUCROSE	C151H8M554	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210593-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2018-07-20

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	537b9a46-ecc8-4537-9657-c9ff7821dd4b	2021-12-03	Warnings	Exact identifier ndc (package): 0363-9980-42 ndc (package): 0363-9980-28 ndc (package): 0363-9980-14 ndc (product): 0363-9980 ndc11 (package): 00363998028 ndc11 (package): 00363998042 ndc11 (package): 00363998014 spl id: 8add376a-81a3-41e0-ba8d-037f7f56165a spl set id: 537b9a46-ecc8-4537-9657-c9ff7821dd4b

Reported adverse events (FAERS/openFDA)#

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