American Sales Company Omeprazole Drug Facts

Manufacturer
American Sales Company
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
weekly-update
Hydrated at
2026-07-17 21:44:08

Label at a glance#

Productcareone omeprazole
Active ingredientOMEPRAZOLE
Label structure9 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 • take 1 tablet before eating in the morning • do not crush or chew tablets • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can...

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); keep product out of high heat and moisture • take the tablet immediately after opening individual blister. Do not store the tablet outside the blister pack for future use.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole 20 mg

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 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 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. 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

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
  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • 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
  • do not take this medicine with alcohol
  • Repeated 14-Day Course (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 before use. 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); keep product out of high heat and moisture
  • take the tablet immediately after opening individual blister. Do not store the tablet outside the blister pack for future use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREone™

MELTech®

Melts In Your Mouth

Compare to Prilosec OTC®

OMEPRAZOLE

Delayed Release Orally Disintegrating Tablets 20 mg

Acid Reducer

Treats FREQUENT Heartburn!

Melts in your mouth

Dissolves without water

Actual Size

Dissolve Tabs

Strawberry Flavor

42 TABLETS

24 HR

Three 14-day courses of treatment

May take 1 to 4 days for full effect

1y9-of-omeprazole.jpg
1y9-of-omeprazole.jpg

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-93941520-939-74, 41520-939-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-03-31full-release2026-06-01 00:58:34

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
N209400-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209400-001100764942036-12-08Drug product2018-09-18
N209400-001108354882036-12-08Drug product2020-11-23

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 22:38:342026-08N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-0584e616aacf4f…
2026-08-18 06:07:402026-07N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-053f01610625f2…
2019-09-15 20:21 UTC2019-09N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD2017-07-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209400-001OMEPRAZOLE20MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALRLD, RS2017-07-05f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N209400-001100764942036-12-08Drug product2018-09-1884e616aacf4f…
2026-09-14 22:38:342026-08N209400-001108354882036-12-08Drug product2020-11-2384e616aacf4f…
2026-08-18 06:07:402026-07N209400-001100764942036-12-08Drug product2018-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209400-001108354882036-12-08Drug product2020-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209400-001100764942036-12-08Drug product2018-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209400-001108354882036-12-08Drug product2020-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209400-001100764942036-12-08Drug product2018-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209400-001108354882036-12-08Drug product2020-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N209400-001100764942036-12-08Drug product2018-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209400-001108354882036-12-08Drug product2020-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209400-001100764942036-12-08Drug product2018-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209400-001108354882036-12-08Drug product2020-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209400-001100764942036-12-08Drug product2018-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209400-001108354882036-12-08Drug product2020-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209400-001100764942036-12-08Drug product2018-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209400-001108354882036-12-08Drug product2020-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209400-001100764942036-12-08Drug product2018-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209400-001108354882036-12-08Drug product2020-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209400-001100764942036-12-08Drug product2018-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209400-001108354882036-12-08Drug product2020-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209400-001100764942036-12-08Drug product2018-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209400-001108354882036-12-08Drug product2020-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209400-001100764942036-12-08Drug product2018-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N209400-001108354882036-12-08Drug product2020-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209400-001100764942036-12-08Drug product2018-09-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209400-001108354882036-12-08Drug product2020-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209400-001100764942036-12-08Drug product2018-09-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209400-001108354882036-12-08Drug product2020-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209400-001100764942036-12-08Drug product2018-09-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209400-001108354882036-12-08Drug product2020-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209400-001100764942036-12-08Drug product2018-09-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N209400-001108354882036-12-08Drug product2020-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209400-001100764942036-12-08Drug product2018-09-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209400-001108354882036-12-08Drug product2020-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209400-001100764942036-12-08Drug product2018-09-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209400-001108354882036-12-08Drug product2020-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209400-001100764942036-12-08Drug product2018-09-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209400-001108354882036-12-08Drug product2020-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209400-001100764942036-12-08Drug product2018-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209400-001100764942036-12-08Drug product2018-09-18bb7c543d1eb4…

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
careone omeprazoleOMEPRAZOLEAmerican Sales Company5b88717a-e90c-4e74-ae2a-29270e14a3cc2026-07-08WarningsExact identifier
ndc (package): 41520-939-74
ndc (package): 41520-939-55
ndc (product): 41520-939
ndc11 (package): 41520093974
ndc11 (package): 41520093955
spl id: 7a2142d9-ea48-4cd8-bb1a-aed470b43852
spl set id: 5b88717a-e90c-4e74-ae2a-29270e14a3cc

Reported adverse events (FAERS/openFDA)#

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