FDA.reportPublic FDA data

Sodium Bicarbonate

Manufacturer
Cardinal Health 107, LLC
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:36:25

Label at a glance#

ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure9 sections

Indications and uses

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

Dosage and administration

  See product insert for prescribing information, precautions and warnings. • Do not use the maximum dosage for more than 2 weeks • Tablets may be swallowed whole or dissolved in water prior to use • Adults 60 years of age or over: 1-2 every 4 hours, not more than 12 tablets in 24 hours. • Adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

In each tablet: Sodium Bicarbonate 10 gr (650 mg)

  • Each tablet contains: sodium 178 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Indications and Usage

INDICATIONS & USAGE SECTION

Relieves -

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

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Warnings

WARNINGS SECTION

This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

Ask a doctor before use if you have a sodium restricted diet.

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks.

If you are pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • See product insert for prescribing information, precautions and warnings.
  • Do not use the maximum dosage for more than 2 weeks
  • Tablets may be swallowed whole or dissolved in water prior to use
  • Adults 60 years of age or over: 1-2 every 4 hours, not more than 12 tablets in 24 hours.
  • Adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

Storage and Handling

STORAGE AND HANDLING SECTION

Store at room temperature 15° - 30°C (59° - 86°F)

Other

SPL UNCLASSIFIED SECTION

Manufactured For and Distributed By:

Hospak® Unit Dose Products, Huntley, IL 60142

Questions or comments? 1-847-458-5308

Hospak®

Distributed By:

Cardinal Health

Dublin, OH 43017

L40866170518

Rev. 8/17

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SODIUM BICARBONATE, USP

650 mg (10 Grain)

ANTACID TABLETS

10 TABLETS

650mg bag label
650mg bag label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN6
198861sodium bicarbonate 650 MG Oral TabletSCD6
198861NaHCO3 650 MG Oral TabletSY6
198861sodium bicarbonate 10 Grains Oral TabletSY6
198861sodium bicarbonate 648 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55154-6754-02024-11-08C16284748780-1f386c649-b3d1-0266-e053-dadaa90a7c1aSodium Bicarbonate 650 mg (10 grain)
55154-6754-02023-01-30C16284748780-1f386c649-b3d1-0266-e053-dadaa90a7c1aSodium Bicarbonate 650 mg (10 grain)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-6754-0Sodium Bicarbonate1 in 1 BLISTER PACKTABLET16
55154-6754-0Sodium Bicarbonate10 in 1 BAGTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6754SODIUM BICARBONATE TABLET [CARDINAL HEALTH 107, LLC]6Current NDC, Legacy NDC, 2 package rows20241109_f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO1
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q201
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-675455154-6754-0

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
MINERAL OILT5L8T28FGPIACT
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 BicarbonateSODIUM BICARBONATECardinal Health 107, LLCf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f2024-11-07WarningsExact identifier
ndc (package): 55154-6754-0
ndc (product): 55154-6754
ndc11 (package): 55154675400
spl id: 73bf9e65-e5f5-4439-b4cf-a9e43214280e
spl set id: f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f

Reported adverse events (FAERS/openFDA)#

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