FDA.reportPublic FDA data

Omeprazole Delayed Release Tablets

Manufacturer
Dr. Reddys Laboratories Inc | Dr.Reddy's Laboratories Limited (SEZ UNIT)
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:47:27

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...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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

Distributed by:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Revised: 10/2022

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container carton: 14's pack

containercartoncontainercarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN7
402014omeprazole 20 MG Delayed Release Oral TabletSCD7
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-286-25Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE147
43598-286-25Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
43598-286-27Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
43598-286-32Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
43598-286-33Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37
43598-286-37Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37
43598-286-37Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE147
43598-286-52Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
43598-286-70Omeprazole7 in 1 BLISTER PACKTABLET, DELAYED RELEASE77
43598-286-74Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE17
43598-286-74Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-286OMEPRAZOLE TABLET, DELAYED RELEASE [DR. REDDYS LABORATORIES INC]7Current NDC, Legacy NDC, 11 package rows20241222_4b3b389d-a151-d851-cb05-64eb49979e5e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-286-33EA - Each43598-28642067ff0-a05a-4cf1-a797-5af13391fee412024-11-05
43598-286-52EA - Each43598-286df0c4c77-a812-44e6-add5-fb5148d2a50212024-11-05

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43598-28643598-286-52, 43598-286-27, 43598-286-33, 43598-286-74, 43598-286-25, 43598-286-37, 43598-286-70, 43598-286-32

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
NameUNIIKind
OMEPRAZOLEKG60484QX9ACTIB
AMMONIA5138Q19F1XIACT
CARNAUBA WAXR12CBM0EIZIACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)6N003M473WIACT
HYPROMELLOSES3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MONOETHANOLAMINE5KV86114PTIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
Polyethylene Glycol 3350G2M7P15E5PIACT
POLYVINYL ALCOHOL532B59J990IACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM STEARATEQU7E2XA9TGIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SHELLAC46N107B71OIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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 44.

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
A207740-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05c2088c7a36db…
2026-09-14 22:38:342026-08A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-053f01610625f2…
2019-09-15 20:21 UTC2019-09A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207740-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORAL2018-11-053a93d1ddd44b…

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
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Inc4b3b389d-a151-d851-cb05-64eb49979e5e2024-12-19WarningsExact identifier
ndc (package): 43598-286-32
ndc (package): 43598-286-25
ndc (package): 43598-286-37
ndc (package): 43598-286-52
ndc (package): 43598-286-74
ndc (package): 43598-286-33
ndc (package): 43598-286-70
ndc (package): 43598-286-27
ndc (product): 43598-286
ndc11 (package): 43598028652
ndc11 (package): 43598028633
ndc11 (package): 43598028637
ndc11 (package): 43598028674
ndc11 (package): 43598028670
ndc11 (package): 43598028627
ndc11 (package): 43598028632
ndc11 (package): 43598028625
spl id: ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4
spl set id: 4b3b389d-a151-d851-cb05-64eb49979e5e

Reported adverse events (FAERS/openFDA)#

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