Sodium Bicarbonate

Manufacturer
Humco Holding Group, Inc.
Effective date
2020-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:28

Label at a glance#

ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure12 sections

Dosage and administration

Adult and children 6 yrs of age and older: Take 1/2 tsp. in 1/2 g;ass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION


Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Soduim Bicarbonate, USP

Purpose

OTC - PURPOSE SECTION

Antacid

Use

INDICATIONS & USAGE SECTION

For relief of heartburn, acid indigestion, and upset stomach associated with these symptoms.

Warnings NOT FOR INJECTIONS

WARNINGS SECTION

Except under supervision of a doctor do not administer to children under 6 years of age.

Do not take more than six, 1/2 tsp. per person up to 60 years old, or three 1/2 tsp. per person 60 years or older in a 24 hour period.

Do not use this product if you are on a sodium restricted diet (each 1/2 tsp. contains 30 mEq (0.7 g) Sodium).

Do not use the maximum does more than 2 weeks.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are currently taking a prescription drug. Antacids may interact with certain prescription drugs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 6 yrs of age and older:

Take 1/2 tsp. in 1/2 g;ass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Premier Value Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 oz

PV 4PV 4

16 oz

PV 16PV 16

Vida Mia Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VMVM

Medis Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medis NaBicarb.jpgMedis NaBicarb.jpg

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
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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
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
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9124-012022-07-29C16284748780-1e4f33bdf-a6a3-d8a0-e053-dadaa90a6e4ePrivate Label Sodium Bicarbonate
0395-9124-942022-07-29C16284748780-1e4f33bdf-a6a3-d8a0-e053-dadaa90a6e4ePrivate Label Sodium Bicarbonate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9124-01Sodium Bicarbonate454 g in 1 BOTTLE, PLASTICPOWDER4543
0395-9124-94Sodium Bicarbonate113 g in 1 BOTTLE, PLASTICPOWDER1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9124SODIUM BICARBONATE POWDER [HUMCO HOLDING GROUP, INC.]3Legacy NDC, 2 package rows20200622_606524be-6896-dd7a-e053-2991aa0a228e.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91240395-9124-01, 0395-9124-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
a8859347-4b3b-5572-e053-2a95a90a1e8f606524be-6896-dd7a-e053-2991aa0a228e2020-06-20WarningsExact identifier
spl id: a8859347-4b3b-5572-e053-2a95a90a1e8f
spl set id: 606524be-6896-dd7a-e053-2991aa0a228e

Reported adverse events (FAERS/openFDA)#

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