topcare omeprazole and sodium bicarbonate

Manufacturer
Topco Associates LLC
Effective date
2017-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:17:03

Label at a glance#

Producttopcare omeprazole and sodium bicarbonate
Active ingredientOMEPRAZOLE, SODIUM BICARBONATE
Label structure15 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, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • d...

Storage and handling

• each capsule contains: sodium 303 mg • read the directions, warnings and accompanying label information before use • store at 20-25 o C (68-77 o F) • tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing. • keep product out of high heat and humidity • protect product from moisture

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Allows absorption of this omeprazole product

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

Do not use if you have:

OTC - DO NOT USE SECTION

  • trouble or pain swallowing food
  • vomiting with blood
  • bloody or black stools

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.
  • 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
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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)
  • any other prescription drugs. Sodium bicarbonate 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

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, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

  • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
  • take every day for 14 days
  • do not take more than 1 capsule a day
  • do not chew or crush the capsule
  • do not open capsule and sprinkle on food
  • do not use for more than 14 days unless directed by your doctor

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

  • each capsule contains: sodium 303 mg
  • read the directions, warnings and accompanying label information before use
  • store at 20-25oC (68-77oF)
  • tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing.
  • keep product out of high heat and humidity
  • protect product from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TREATS FREQUENT HEARTBURN

Omeprazole and Sodium Bicarbonate

CAPSULES 20 mg / 1100 mg

Acid Reducer

Allows Absorption of this Omeprazole Product

COMPARE TO ZEGERID OTC® active ingredients

actual size

42 CAPSULES

Three 14-day courses of treatment

Topcare omeprazole and sodium bicarbonate
Topcare omeprazole and sodium bicarbonate
Topcare omeprazole and sodium bicarbonate
Topcare omeprazole and sodium bicarbonate

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-73236800-732-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 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
A201361-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15

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 22:38:342026-08A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1584e616aacf4f…
2026-08-18 06:07:402026-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153f01610625f2…
2019-09-15 20:21 UTC2019-09A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15f41ea6bd6efb…

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b5dc545a-53d4-49f8-b082-8a6bb869a6c2a6711c47-e0cf-4ef1-a16e-606e6522a10e2021-01-27WarningsExact identifier
spl set id: a6711c47-e0cf-4ef1-a16e-606e6522a10e

Reported adverse events (FAERS/openFDA)#

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