Omeprazole Delayed Release Tablets

Manufacturer: BluePoint Laboratories | Dr.Reddy's Laboratories Limited (SEZ UNIT)
Effective date: 2026-09-27
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: daily-update
Hydrated at: 2026-09-30 01:02:17

Label at a glance#

ProductOmeprazole

Active ingredientOMEPRAZOLE

Label structure10 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 1 tablet a day do not use for more than 14 days unless di...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole USP, 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use(s)

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 lightheadednes
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 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

swallow 1 tablet with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 tablet a day
do not use for 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

ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate, yellow iron oxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-375-3784

*This product is not manufactured or distributed by Procter & Gamble, distributor of Prilosec OTC®. Prilosec OTC® is a registered trademark of AstraZeneca AB.

Manufactured for:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

For BluePoint Laboratories

Made in India

Revised:12/22

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Omeprazole Tablets CartonOmeprazole Delayed-Release Tablets 20mg 14ct Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Omeprazole Tablets LabelOmeprazole Delayed-Release Tablets 20mg 14ct Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-441-39	EA - Each	68001-441	b9f2615f-136c-48a3-8d62-89c8aec834d8	1	2020-09-14
68001-441-40	EA - Each	68001-441	bddc9777-1448-465c-9d50-440abcb95231	1	2020-09-14
68001-441-55	EA - Each	68001-441	0720290b-f2aa-41e2-9b89-667f6bda4861	1	2022-06-06
68001-441-98	EA - Each	68001-441	ea82b9cb-7b5a-43b5-a198-60bcb9e85c02	1	2020-09-14

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

Omeprazole
AMMONIA
CARNAUBA WAX
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
HYPROMELLOSES
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MONOETHANOLAMINE
BUTYL ALCOHOL
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL
POVIDONE
PROPYLENE GLYCOL
FERRIC OXIDE RED
SODIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SHELLAC
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
FERRIC OXIDE YELLOW
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68001-441	68001-441-55, 68001-441-98, 68001-441-39, 68001-441-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OMEPRAZOLE	KG60484QX9	ACTIB
AMMONIA	5138Q19F1X	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)	6N003M473W	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MONOETHANOLAMINE	5KV86114PT	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
POVIDONE	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
SODIUM STEARATE	QU7E2XA9TG	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
SHELLAC	46N107B71O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
5	2023-09-13	full-release	2026-05-31 23:56:09

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
A207740-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL			2018-11-05

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	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207740-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-11-05	`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	BluePoint Laboratories	a86d52a5-15e2-012d-e053-2a95a90ac912	2023-09-13	Warnings	Exact identifier ndc (package): 68001-441-55 ndc (package): 68001-441-40 ndc (package): 68001-441-39 ndc (package): 68001-441-98 ndc (product): 68001-441 ndc11 (package): 68001044139 ndc11 (package): 68001044198 ndc11 (package): 68001044140 ndc11 (package): 68001044155 spl set id: a86d52a5-15e2-012d-e053-2a95a90ac912

Reported adverse events (FAERS/openFDA)#

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