Home DailyMed a6711c47-e0cf-4ef1-a16e-606e6522a10e topcare omeprazole and sodium bicarbonate Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
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# Product topcare omeprazole and sodium bicarbonate
Active ingredient OMEPRAZOLE, SODIUM BICARBONATE
Label structure 15 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
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 13 matching rows.
topcare omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate OMEPRAZOLE SODIUM BICARBONATE SODIUM CATION BICARBONATE ION FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN POLYSORBATE 80 SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 9 matching rows.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 f41ea6bd6efb…
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