FDA.reportPublic FDA data

Sodium Bicarbonate

Manufacturer
Advanced Rx LLC | Ocean Healthcare Pvt Ltd
Effective date
2025-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:19

Label at a glance#

ProductSodium Bicarbonate 10 GR (650 MG)
Active ingredientSODIUM BICARBONATE
Label structure14 sections

Indications and uses

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

Dosage and administration

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 and over: 1-2 tablets 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

Storage and handling

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

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 takemore 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 maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a sodium restricted diet.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a presciption drug. Antacids may intract with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms last more than 2 weeks.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 and over: 1-2 tablets 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline cellulose, stearic acid.

SPL UNCLASSIFIED SECTION

TEMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

ADVANCED RX LLC

1942 NE 163rd St North Miami Beach,

FL33162 U.S.A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN1
198861sodium bicarbonate 650 MG Oral TabletSCD1
198861NaHCO3 650 MG Oral TabletSY1
198861sodium bicarbonate 10 Grains Oral TabletSY1
198861sodium bicarbonate 648 MG Oral TabletSY1

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
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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
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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
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-611-02Sodium Bicarbonate10 GR (650 MG)200 in 1 BOTTLETABLET2001

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
80513-61180513-611-02

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
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 GR (650 MG)SODIUM BICARBONATEAdvanced Rx LLC634e8d52-6d04-42f9-98f6-2634473b5dfd2025-09-01WarningsExact identifier
ndc (package): 80513-611-02
ndc (product): 80513-611
ndc11 (package): 80513061102
spl id: 3d912fde-5c7a-e74c-e063-6394a90a6e1f
spl set id: 634e8d52-6d04-42f9-98f6-2634473b5dfd

Reported adverse events (FAERS/openFDA)#

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