FDA.reportPublic FDA data

SODIUM BICARBONATE

Manufacturer
Richmond Pharmaceuticals, Inc. | Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:52:50

Label at a glance#

ProductSODIUM BICARBONATE
Active ingredientSODIUM BICARBONATE
Label structure11 sections

Dosage and administration

Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours Dissolve tabelt completely in water before drinking. DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Storage and handling

each tablet contains: sodium 178 mg  store at room temperature 15 ° - 30 ° C (59 ° - 86 ° F).

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

PURPOSE

OTC - PURPOSE SECTION

Antacid

Indications:

INDICATIONS & USAGE SECTION

Relieves:

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

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist

OTC - ASK DOCTOR SECTION

  • if you are on a sodium-restricted diet.
  • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
  • if symptons last more than 2 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours
  • Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours
  • Dissolve tabelt completely in water before drinking.
  • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information:

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 178 mg 
  • store at room temperature 15 °- 30 °C (59 °- 86 °F).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

OVERDOSAGE SECTION

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

croscarmellose sodium, microcrystalline cellulose, stearic acid

Questions or Comments

OTC - QUESTIONS SECTION

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

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMG_4670
IMG_4670

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN3
198861sodium bicarbonate 650 MG Oral TabletSCD3
198861NaHCO3 650 MG Oral TabletSY3
198861sodium bicarbonate 10 Grains Oral TabletSY3
198861sodium bicarbonate 648 MG Oral TabletSY3

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-130054738020038GTIN-13: 0054738020038
EAN-13: 0054738020038
GTIN-12: 054738020038
UPC-A: 054738020038
GTIN storage (14 digits): 00054738020038		IMG_4670.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-020-03SODIUM BICARBONATE1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-020SODIUM BICARBONATE TABLET [RICHMOND PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20171030_fa10d93d-b3ed-4675-a117-f573d9e72bca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-020-03EA - Each54738-02040fa994f-d590-4fac-932c-6238a8962c4012017-11-06

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
54738-02054738-020-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML · Source PDF

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 BICARBONATERichmond Pharmaceuticals, Inc.fa10d93d-b3ed-4675-a117-f573d9e72bca2017-10-30WarningsExact identifier
ndc (package): 54738-020-03
ndc (product): 54738-020
ndc11 (package): 54738002003
spl id: 5cc6cec2-9f03-6cf9-e053-2991aa0ada77
spl set id: fa10d93d-b3ed-4675-a117-f573d9e72bca

Reported adverse events (FAERS/openFDA)#

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