FDA.reportPublic FDA data

Sodium Bicarbonate Antacid

Manufacturer
Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
Effective date
2017-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:52

Label at a glance#

ProductSodium Bicarbonate Antacid
Active ingredientSODIUM BICARBONATE
Label structure10 sections

Indications and uses

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

Dosage and administration

Directions adults 60 years of age and over: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours do not use the maximum dosage for more than 2 weeks tablets may be swallowed whole or dissolved in water prior to use

Storage and handling

Storage store at room temperature 15 o - 30 o C (59 o - 86 o F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                     Purpose

(in each tablet)

Sodium bicarbonate 5 gr (325 mg) .......      Antacid

Purpose

OTC - PURPOSE SECTION

Purpose                      Antacid


Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

Warnings

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

Ask a doctor or pharmacist before use of 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 pregnant or breast-feeding, ask a health professional before use.

This package for households without young children. 

Each tablet contains: sodium 89 mg

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults 60 years of age and over: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours
  • adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks
  • tablets may be swallowed whole or dissolved in water prior to use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

croscarmellose sodium, microcrystalline cellulose, stearic acid

Storage

STORAGE AND HANDLING SECTION

Storage

store at room temperature 15 o - 30 o C (59 o - 86 o F)

Questions?

OTC - QUESTIONS SECTION

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

Sodium Bicarbonate Antacid Tablet

5 ​​gr (325 mg)

1000 White Tablets

NDC-  54738-035-03

image1image1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198859sodium bicarbonate 325 MG Oral TabletPSN2
198859sodium bicarbonate 325 MG Oral TabletSCD2
198859NaHCO3 325 MG Oral TabletSY2
198859sodium bicarbonate 324 MG Oral TabletSY2
198859sodium bicarbonate 5 Grains Oral TabletSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130054738035032GTIN-13: 0054738035032
EAN-13: 0054738035032
GTIN-12: 054738035032
UPC-A: 054738035032
GTIN storage (14 digits): 00054738035032		image1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-035-03Sodium Bicarbonate Antacid1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-035SODIUM BICARBONATE ANTACID (SODIUM BICARBONATE) TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20171101_e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-035-03EA - Each54738-0350c63a545-8b28-4562-a7f7-b128810d30df12018-10-11

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54738-03554738-035-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
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 AntacidSODIUM BICARBONATERichmond Pharmaceuticals, Inc.e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce2017-11-01WarningsExact identifier
ndc (package): 54738-035-03
ndc (product): 54738-035
ndc11 (package): 54738003503
spl id: 5cec472c-8a20-32e5-e053-2991aa0a3222
spl set id: e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce

Reported adverse events (FAERS/openFDA)#

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