FDA.reportPublic FDA data

Sodium Bicarbonate 5 gr

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2021-08-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:21

Label at a glance#

ProductSodium Bicarbonate 5 gr
Active ingredientSODIUM BICARBONATE
Label structure12 sections

Storage and handling

Other information each tablet contains: sodium 89 mg store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sodium bicarbonate 5 gr

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses relieves

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use the maximum dosage for more than 2 weeks
  • dissolve tablets completely in water prior to use
  • adults 60 years of age and over: 2-8 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

STORAGE AND HANDLING SECTION

Other information

  • each tablet contains: sodium 89 mg
  • store at room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

croscarmellose sodium, microcrystalline cellulose, stearic acid

OTC - QUESTIONS SECTION

Questions or comments?

call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-035-10

Sodium Bicarbonate 5 gr

ANTACID

1000 TABLETS

SodiumSodium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198859sodium bicarbonate 325 MG Oral TabletPSN4
198859sodium bicarbonate 325 MG Oral TabletSCD4
198859NaHCO3 325 MG Oral TabletSY4
198859sodium bicarbonate 324 MG Oral TabletSY4
198859sodium bicarbonate 5 Grains Oral TabletSY4

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
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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
69618-035-102023-01-30C16284748780-19d75b9d0-4147-f424-e053-dadaa90a57ceReliable-1 Sodium Bicarbonate 5 gr
69618-035-102021-09-11C16284748780-19d75b9d0-4147-f424-e053-dadaa90a57ceReliable-1 Sodium Bicarbonate 5 gr
69618-035-102020-01-31C16284748780-19d75b9d0-4147-f424-e053-dadaa90a57ceReliable-1 Sodium Bicarbonate 5 gr

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-035-10Sodium Bicarbonate 5 gr1000 in 1 BOTTLE, PLASTICTABLET, SOLUBLE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-035SODIUM BICARBONATE 5 GR (SODIUM BICARBONATE) TABLET, SOLUBLE [RELIABLE 1 LABORATORIES LLC]4Legacy NDC, 1 package rows20210915_31e090e9-5421-4b45-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-035-10EA - Each69618-0359b33f7df-73d1-47d6-9a3a-4cb5cf6aca7b12016-05-16

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-03569618-035-10

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
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
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
cb80e7ee-5958-f45a-e053-2a95a90adbac31e090e9-5421-4b45-e054-00144ff8d46c2021-08-09WarningsExact identifier
spl id: cb80e7ee-5958-f45a-e053-2a95a90adbac
spl set id: 31e090e9-5421-4b45-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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