FDA.reportPublic FDA data

Sodium Bicarbonate 10 gr

Manufacturer
GRAXCELL PHARMACEUTICAL, LLC
Effective date
2025-12-25
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:28:44

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN9
198861sodium bicarbonate 650 MG Oral TabletSCD9
198861NaHCO3 650 MG Oral TabletSY9
198861sodium bicarbonate 10 Grains Oral TabletSY9
198861sodium bicarbonate 648 MG Oral TabletSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

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
70795-1190-12025-12-25C16284748780-11030e365-5054-111a-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
70795-1190-52025-12-25C16284748780-11030e365-5054-111a-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
70795-1190-12024-01-30C16284748780-11030e365-5054-111a-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
70795-1190-52024-01-30C16284748780-11030e365-5054-111a-e063-dadaa90a10e2Sodium Bicarbonate 10 gr (650 mg), 70795-1190

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70795-1190-0Sodium Bicarbonate 10 gr1000 in 1 BOTTLETABLET10009
70795-1190-1Sodium Bicarbonate 10 gr100 in 1 BOTTLETABLET1009
70795-1190-2Sodium Bicarbonate 10 gr200 in 1 BOTTLETABLET2009
70795-1190-5Sodium Bicarbonate 10 gr500 in 1 BOTTLETABLET5009

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
STARCH, CORNO8232NY3SJIACT
MINERAL OILT5L8T28FGPIACT
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML

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
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
ndc (package): 70795-1190-0
ndc (package): 70795-1190-1
ndc (package): 70795-1190-2
ndc (package): 70795-1190-5
ndc (product): 70795-1190
ndc11 (package): 70795119001
ndc11 (package): 70795119000
ndc11 (package): 70795119002
ndc11 (package): 70795119005
spl id: 46cfbf8a-0ee3-a51f-e063-6394a90a063c
spl set id: 897dbb09-fb47-4e03-8cae-bf76d48a7a03

Reported adverse events (FAERS/openFDA)#

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