FDA.reportPublic FDA data

SODIUM BICARBONATE ANTACID

Manufacturer
Dannso Corp./d.b.a. Essential Products | World Perfume, Inc
Effective date
2016-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:58

Label at a glance#

ProductSODIUM BICARBONATE ANTACID
Active ingredientSODIUM BICARBONATE
Label structure10 sections

Indications and uses

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

Dosage and administration

take ½ level teaspoon in ½ glass (4 fl. oz.) of water every 2 hours up to maximum dosage or as directed by a doctor. Dissolve completely in water before drinking. Age Maximum Dosage Adults 60 years and over Do not exceed three doses of 1/2 teaspoon in a 24 hour period. Adults and children 12 years and over Do not exceed six doses of 1/2 teaspoon in a 24 hour period. Children under 12 years Do not use. Do not excee...

Storage and handling

each 1/2 teaspoon dose contains: sodium 716 mg

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - ACTIVE INGREDIENT SECTION

Sodium bicarbonate USP 2,616 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves:

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

Warnings

WARNINGS SECTION

FOR ORAL USE ONLY

Do not use if Tamper Evident Seal is missing or broken.

STOMACH WARNING

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

Do not use in children under 12 years of age.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a sodium-restricted diet.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take ½ level teaspoon in ½ glass (4 fl. oz.) of water every 2 hours up to maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.
AgeMaximum Dosage
Adults 60 years and overDo not exceed three doses of 1/2 teaspoon in a 24 hour period.
Adults and children 12 years and overDo not exceed six doses of 1/2 teaspoon in a 24 hour period.
Children under 12 yearsDo not use.

Do not exceed recommended dosage. See warnings.

Other information

STORAGE AND HANDLING SECTION

  • each 1/2 teaspoon dose contains: sodium 716 mg

Questions or Comments

SPL UNCLASSIFIED SECTION

Distributed by

Essential Products Miami FL 33126

www.jjjdistributors.com

Made in U.S.A.

Questions

OTC - QUESTIONS SECTION

1-800-858-3889

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

De La Cruz®

Sodium
Bicarbonate
USP
- Oral Powder -

Antacid

NET WT 4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label
PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1488624sodium bicarbonate 2.6 GM Powder for Oral SolutionPSN1
1488624sodium bicarbonate 2600 MG Powder for Oral SolutionSCD1
1488624NaHCO3 2600 MG Powder for Oral SolutionSY1
1488624sodium bicarbonate 2.6 GM Powder for Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70242-131-042020-01-31C16284748780-19d75b9d0-7894-f424-e053-dadaa90a57ceSODIUM BICARBONATE ANTACID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70242-131-04SODIUM BICARBONATE ANTACID113 g in 1 BOTTLE, PLASTICPOWDER1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70242-131SODIUM BICARBONATE ANTACID (SODIUM BICARBONATE) POWDER [DANNSO CORP./D.B.A. ESSENTIAL PRODUCTS]1Legacy NDC, 1 package rows20160829_79702bcd-65c4-4265-8139-93d93e983e75.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
70242-13170242-131-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML · Source PDF

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
17197886-8f32-41a8-afa9-6f2c53a83bd179702bcd-65c4-4265-8139-93d93e983e752016-01-01WarningsExact identifier
spl id: 17197886-8f32-41a8-afa9-6f2c53a83bd1
spl set id: 79702bcd-65c4-4265-8139-93d93e983e75

Reported adverse events (FAERS/openFDA)#

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