Omeprazole Delayed Release Tablets

Manufacturer
Thirty Madison Inc | Dr.Reddy's Laboratories Limited (SEZ UNIT) | Reed Lane Inc
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:51:01

Label at a glance#

ProductOmeprazole
Active ingredientOMEPRAZOLE
Label structure12 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 relief of symptoms within 24 hours • 14 day course of treatment •swallow 1 tablet with a glass of water befre 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...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole USP, 20mg

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 SECTION

Allergy alert

WARNINGS 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

Ask a doctor or Pharmacist beofre using if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking:

• warfarin, clopidogrel or cilostazol (blood thinning medications)

• prescription antifungal or anti-yeast medicines

• diazepam (anxiety medicine)

• digoxin (heart medicine)

• tacrolimus or mycophenolate mofetil (immune system medicines)

• prescription antiretrovirals (medicines for HIV infection)

• methotrexate (arthritis medicine)

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 treatement 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 (1800-222-1222)

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 relief of symptoms within 24 hours

• 14 day course of treatment

•swallow 1 tablet with a glass of water befre 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 days 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, titanim dioxide, triethyl citrate, yellow iron oxide

Questions or comments?

SPL UNCLASSIFIED SECTION

call 1-888-375-3784

Tips for Managing Heartburn

SPL UNCLASSIFIED SECTION

• Do not lie flat or bend over after eating

• Do not wear tight-fitting clothing around the stomach

• Do not eat before bedtime

• Raise the head of your bed

• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables

• Eat slowly and avoid big meals

• If overweight, lose weight

• Quit smoking

Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71713-201OMEPRAZOLE TABLET, DELAYED RELEASE [THIRTY MADISON INC]3Legacy NDC20241030_b7289621-9dc7-fd2b-bbb1-f69dea450f7d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71713-201-03EA - Each71713-20112b17266-8c8e-4ff4-b870-d6d65a9056fd12022-06-06
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
71713-20171713-201-01, 71713-201-03
43598-286

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bc246c0a-092e-9386-4674-d4fb8932f2ecb7289621-9dc7-fd2b-bbb1-f69dea450f7d2025-12-01WarningsExact identifier
spl set id: b7289621-9dc7-fd2b-bbb1-f69dea450f7d
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Inc4b3b389d-a151-d851-cb05-64eb49979e5e2024-12-19WarningsExact identifier
ndc (product): 43598-286

Reported adverse events (FAERS/openFDA)#

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