FDA.reportPublic FDA data

Sodium Bicarbonate Tablets

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2020-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:29

Label at a glance#

ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure11 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 dissolve tablets completely in water prior to use 325mg, 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 650mg, adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours adults under ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SODIUM BICARBONATE - sodium bicarbonate tablet

Marlex Pharmaceuticals, Inc.      

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Bicarbonate

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sodium bicarbonate 10 gr (650 mg)

Sodium bicarbonate 5gr (325 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

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 prescription drug. Antacids may interact 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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use the maximum dosage for more than 2 weeks
  • dissolve tablets completely in water prior to use

325mg,

  • 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

650mg,

  • 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

SAFE HANDLING WARNING SECTION

  •  each tablet contains: sodium 89mg (325mg) 
  • store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP

     sodium 178 mg (650mg) 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Pregelatinized starch, NF and mineral oil, USP

 Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-266-8818

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

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count650 mg
6071610-445-53
9071610-445-60
18071610-445-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20200723JH

PRINCIPAL DISPLAY PANEL - 650 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-445 - Sodium Bicarbonate 650 mg Tablets
Bottle Label 650 mgBottle Label 650 mg

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-445-532023-01-30C16284748780-1f386c649-fde1-0266-e053-dadaa90a7c1aSodium Bicarbonate Tablets
71610-445-602023-01-30C16284748780-1f386c649-fde1-0266-e053-dadaa90a7c1aSodium Bicarbonate Tablets
71610-445-802023-01-30C16284748780-1f386c649-fde1-0266-e053-dadaa90a7c1aSodium Bicarbonate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-445-53Sodium Bicarbonate60 in 1 BOTTLETABLET601
71610-445-60Sodium Bicarbonate90 in 1 BOTTLETABLET901
71610-445-80Sodium Bicarbonate180 in 1 BOTTLETABLET1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-445SODIUM BICARBONATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20200725_2928c7d3-1bcf-49cf-af9f-baabf4f7da27.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-445-53EA - Each71610-445729ef9fd-4c31-4d4f-8b92-2b52161b7c1112021-11-09
71610-445-60EA - Each71610-445aef4e80f-9580-4e53-ac71-2f772761b27912020-09-14
71610-445-80EA - Each71610-44500147962-11db-4ad8-ae6f-9c2d2e00fd0712020-09-14
10135-685-10EA - Each10135-6856172b655-c454-470b-a1e0-27827801de5412020-04-20

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
71610-44571610-445-53, 71610-445-60, 71610-445-80
10135-685

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
STARCH, CORNO8232NY3SJIACT
MINERAL OILT5L8T28FGPIACT

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
18daabfe-0f66-436b-bb87-d8694d00767b2928c7d3-1bcf-49cf-af9f-baabf4f7da272020-07-23WarningsExact identifier
spl id: 18daabfe-0f66-436b-bb87-d8694d00767b
spl set id: 2928c7d3-1bcf-49cf-af9f-baabf4f7da27

Reported adverse events (FAERS/openFDA)#

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