FDA.reportPublic FDA data

Prilosec OTC

Manufacturer
REMEDYREPACK INC.
Effective date
2022-03-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:05:09

Label at a glance#

ProductPrilosec OTC
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 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 20-25°C (68-77°F) and protect from moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)

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

OTC - DO NOT USE SECTION

Do not use if you have:

  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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

  • warfarin, clopidogrel, or cilostazol (blood-thinning medicines)
  • 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)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

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.

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 20-25°C (68-77°F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Questions?

OTC - QUESTIONS SECTION

1-800-289-9181

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Prilosec OTC

GENERIC: omeprazole magnesium

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2167-0

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 15 mm

IMPRINT: P

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • OMEPRAZOLE MAGNESIUM 20.6mg in 1

INACTIVE INGREDIENT(S):

  • GLYCERYL MONOSTEARATE
  • HYDROXYPROPYL CELLULOSE
  • HYPROMELLOSES
  • FERRIC OXIDE RED
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • PARAFFIN
  • POLYETHYLENE GLYCOL 6000
  • POLYSORBATE 80
  • SODIUM STEARYL FUMARATE
  • SUCROSE
  • TALC
  • TITANIUM DIOXIDE
  • TRIETHYL CITRATE

Remedy_LabelRemedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-455-02EA - Each37000-45583d26bbf-1b1f-4662-839b-27147bd01cd912012-07-24
37000-455-03EA - Each37000-455f89a1e94-a00b-423d-bf01-2f9fc14a259b12012-07-24
37000-455-04EA - Each37000-45532829c14-995e-4463-9139-48bea577867e12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-216770518-2167-0
37000-455

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
HYPROMELLOSES3NXW29V3WOIACT
FERRIC OXIDE RED1K09F3G675IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
PARAFFINI9O0E3H2ZEIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
OMEPRAZOLE MAGNESIUM426QFE7XLKACTIM

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
N021229-001PRILOSEC OTCOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD2003-06-20

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD2003-06-20c2088c7a36db…
2026-09-14 22:38:342026-08N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2084e616aacf4f…
2026-08-18 06:07:402026-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-2087673890dc5c…
2021-03-12 10:30 UTC2021-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203f01610625f2…
2019-09-15 20:21 UTC2019-09N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203f0d92c62455…
2023-05-13 08:27 UTC2023-05N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20053a50430f4f…
2023-01-26 05:58 UTC2023-01N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-203a93d1ddd44b…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021229-00164288102019-11-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021229-00164036162019-11-1574a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021229-00164288102019-11-033f01610625f2…
2019-12-14 00:12 UTC2019-12N021229-00164036162019-11-153f01610625f2…
2019-09-15 20:21 UTC2019-09N021229-00164288102019-11-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N021229-00164036162019-11-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N021229-00164288102019-11-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N021229-00164036162019-11-15ea99ee380514…

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
fea87f66-8575-ffef-e053-6294a90abf21677f8593-7488-4fd8-94e7-103c743b00ea2023-06-21WarningsExact identifier
spl set id: 677f8593-7488-4fd8-94e7-103c743b00ea

Reported adverse events (FAERS/openFDA)#

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