Omeprazole Delayed-Release Tablets 20 mg

Manufacturer
INNOVUS PHARMACEUTICALS, INC. | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2026-06-04
Label type
Human OTC Drug Label
Version
3
Source
daily-update
Hydrated at
2026-06-16 05:10:12

Label at a glance#

ProductAcid Reducer
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure17 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...

Storage and handling

read the directions and warnings before use keep the carton. It contains important information. store at 20º to 25ºC (68º to 77º F) and protect from moisture

Label contents#

Full prescribing information#

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

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 allergic reaction occurs, stop use and seek medical help right way.

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 taking a prescription drug.

OTC - ASK DOCTOR/PHARMACIST SECTION

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 (1-800-222-1222)  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 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

STORAGE AND HANDLING SECTION

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20º to 25ºC (68º to 77º F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,  triethyl citrate and yellow iron oxide.

Questions?

OTC - QUESTIONS SECTION

Call 1-855-274-4122

Distributed By:
Innovus Pharmaceuticals, Inc.
Englewood, CO 80112
www.crclehealth.com

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57483-120-14
C'rcle™Heartburn Relief
OmepraCareDR®
Omeprazole
Delayed-Release Tablets
20 mg / Acid Reducer

See current
Drug Facts

24
hour
Treats Frequent Heartburn

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


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient of Prilsec OTC®*NDC 57483-120-42
C'rcle™
Heartburn Relief
OmepraCareDR®
Omeprazole
Delayed-Release Tablets
20 mg / Acid Reducer

See current Drug Facts

24
hour
Treats Frequent Heartburn

42 TABLETS
TRIPLE PACK 3X14 count bottles inside
Three 14-day course of treatment
May take 1 to 4 days for full effect



ACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton LabelACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

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

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-12057483-120-42, 57483-120-14

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-06-15full-release2026-06-01 00:13:46

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
A206877-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-0684e616aacf4f…
2026-08-18 06:07:402026-07A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-063f01610625f2…
2019-09-15 20:21 UTC2019-09A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206877-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2018-06-06f41ea6bd6efb…

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
Acid ReducerOMEPRAZOLEINNOVUS PHARMACEUTICALS, INC.a4e92bd2-8f75-4acc-9b75-df8332bd4cc42026-06-04WarningsExact identifier
ndc (package): 57483-120-42
ndc (package): 57483-120-14
ndc (product): 57483-120
ndc11 (package): 57483012042
ndc11 (package): 57483012014
spl id: 72b23ff2-70a3-412c-9a9c-902927598e2f
spl set id: a4e92bd2-8f75-4acc-9b75-df8332bd4cc4

Reported adverse events (FAERS/openFDA)#

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