FDA.reportPublic FDA data

Sodium Bicarbonate Antacid

Manufacturer
Menper Distributors Inc. | Church & Dwight Co., Inc.
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:08:19

Label at a glance#

ProductSodium Bicarbonate Antacid
Active ingredientSODIUM BICARBONATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each dose=1/2 teaspoon)        Purpose

Sodium bicarbonate USP 2,616 mg ............................ Antacid

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses

Relieves: 

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

WARNINGS SECTION

Warnings

FOR ORAL USE ONLY

STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL POWDER IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FILL FROM FOOD OR DRINK.

Do not use in children under 12 years of age.

Ask a doctor or pharmacist before use if you have a sodium-restricted diet.

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

Stop use and ask a doctor if

  • you have used the maximum dosage for 2 wekks
  • sever stomach pain occurs after using this product

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. In case of overdose, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Take 1/2 teaspoon in 1/2 glass (4 fl. oz.) of water every 2 hours up to a maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.
 Age Maximum Dosage
 Adults 60 years and overDo not exceed three doses of 1/2 teaspoon in a 24 hour period 
 Adults and children 12 years of age and overDo not exceed six doses of 1/2 teaspoon in a 24 hour period 
Children under 12 years Do not use 

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SodiumBicSodiumBic

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
53145-390-042020-01-31C16284748780-19d75b9d1-0fdb-f424-e053-dadaa90a57ceSodium Bicarbonate Antacid
53145-390-082020-01-31C16284748780-19d75b9d1-0fdb-f424-e053-dadaa90a57ceSodium Bicarbonate Antacid
53145-390-162020-01-31C16284748780-19d75b9d1-0fdb-f424-e053-dadaa90a57ceSodium Bicarbonate Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-390-04Sodium Bicarbonate Antacid113 g in 1 BOTTLEPOWDER1133
53145-390-08Sodium Bicarbonate Antacid227 g in 1 BOTTLEPOWDER2273
53145-390-16Sodium Bicarbonate Antacid454 g in 1 BOTTLEPOWDER4543

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
53145-39053145-390-16, 53145-390-08, 53145-390-04

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
SODIUM CATIONLYR4M0NH37IACT
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 AntacidSODIUM BICARBONATEMenper Distributors Inc.6efb4da0-03ae-4df6-acd7-e8023d20d4b32025-07-22WarningsExact identifier
ndc (package): 53145-390-04
ndc (package): 53145-390-08
ndc (package): 53145-390-16
ndc (product): 53145-390
ndc11 (package): 53145039016
ndc11 (package): 53145039008
ndc11 (package): 53145039004
spl id: 3a8afea2-5d9e-1392-e063-6294a90aca43
spl set id: 6efb4da0-03ae-4df6-acd7-e8023d20d4b3

Reported adverse events (FAERS/openFDA)#

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