FDA.reportPublic FDA data

Sodium Bicarbonate 10 gr (650 mg), 70795-1190

Manufacturer
GRAXCELL PHARMACEUTICAL, LLC
Effective date
2026-10-26
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-29 01:01:59

Label at a glance#

ProductSodium Bicarbonate 10 gr
Active ingredientSODIUM BICARBONATE
Label structure10 sections

Indications and uses

Relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms

Dosage and administration

Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking. D0 NOT EXCEED RECOMMENDED DOSE Not recommended for children.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sodium bicarbonate 10 gr (650 mg)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • this product if you are on a sodium-restricted diet unless directed by a doctor
  • Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
  • As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product
Drug Interaction Precaution

DRUG INTERACTIONS SECTION

Stomach Warning

WARNINGS AND PRECAUTIONS SECTION

  • TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK
  • Consult a doctor if severe stomach pain occurs after taking this product.

Drug Interaction Precaution

DRUG INTERACTIONS SECTION

  • Ask a physician or pharmacist before use if you are presently taking a prescription drug
  • Antacids may interact with certain prescription drugs

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: Take 1 tablet, dissolved in a glass of water, as needed. Maxlmum daily dose for adults up to 60 years of age is 24 tablets.

Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.

D0 NOT EXCEED RECOMMENDED DOSE

Not recommended for children.

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains : sodium 178 mg (7.74 meg)
  • store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP

Inactive ingredients

INACTIVE INGREDIENT SECTION

Pregelatinized starch, NF and mineral oil, USP

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-266-8818

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Sodium Bicarbonate_10gr_650mg_1000ct01b LBL_Sodium Bicarbonate_10gr_650mg_1000ct

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70795-1190-02025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-02025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-12025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-12025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-22025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-22025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-52025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-52025-12-25C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-02024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-02024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-12024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-12024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-22024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-22024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-52024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190
70795-1190-52024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70795-119070795-1190-0, 70795-1190-5, 70795-1190-1, 70795-1190-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOACTIB
STARCH, CORNO8232NY3SJIACT
MINERAL OILT5L8T28FGPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-12-25full-release2026-06-01 01:28:44

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
46cfbf8a-0ee3-a51f-e063-6394a90a063c897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
spl set id: 897dbb09-fb47-4e03-8cae-bf76d48a7a03

Reported adverse events (FAERS/openFDA)#

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