FDA.reportPublic FDA data

Sodium Bicarbonate Antacid

Manufacturer
Compania Farmaceutica, S.A. de C.V.
Effective date
2021-04-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:45:09

Label at a glance#

ProductSodium Bicarbonate Antacid
Active ingredientSODIUM BICARBONATE
Label structure8 sections

Indications and uses

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

Dosage and administration

Persons Up To 60 Years Old: Take ¼ to ½ teaspoon up to 4 times a day Persons 60 Years or Older: take ¼ teaspoon up to 4 times a day or ½ teaspoon up to 3 times a day.

Label contents#

Full prescribing information#

Active ingredient (in each 1/2 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Sodium bicarbonate 2.52 g

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use​

  • more than 3 teaspoons for persons up to 60 years old
  • more than 1½ teaspoons for persons 60 years or older in a 24-hour period
  • more than the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Persons Up To 60 Years Old: Take ¼ to ½ teaspoon up to 4 times a day
  • Persons 60 Years or Older: take ¼ teaspoon up to 4 times a day or ½ teaspoon up to 3 times a day.

Other information

SPL UNCLASSIFIED SECTION

  • Sodium Content per ½ tsp. 685 mg
  • Store at 86°F/30°C or cooler

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
71230-00171230-001-12

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

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
c77d4b23-3928-f8cc-e053-2995a90ade3bd7374acb-76ed-4afc-8fd7-e56a7ae5c4ec2021-07-19WarningsExact identifier
spl set id: d7374acb-76ed-4afc-8fd7-e56a7ae5c4ec

Reported adverse events (FAERS/openFDA)#

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