FDA.reportPublic FDA data

SODIUM BICARBONATE

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2017-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:05:52

Label at a glance#

ProductSODIUM BICARBONATE
Active ingredientSODIUM BICARBONATE
Label structure10 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 tablets may be swallowed whole or dissolved in water prior to use adults 60 years of age and over: take 1-2 tablets every 4 hours as needed, or as directed by a doctor. Do not take more than 12 tablets in 24 hours. adults under 60 years of age: take 1-4 tablets every 4 hours as needed, or as directed by a doctor. Do not take more than 24 tablets in 24 hours.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sodium bicarbonate 650 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 a sodium restricted diet

Ask a doctor or pharmacist before use of you are

taking a prescription drug. Antacids may interact with

certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • ​do not use the maximum dosage for more than 2 weeks
  • tablets may be swallowed whole or dissolved in water prior to use
  • adults 60 years of age and over: take 1-2 tablets every 4 hours as needed, or as directed by a doctor. Do not take more than 12 tablets in 24 hours.
  • adults under 60 years of age: take 1-4 tablets every 4 hours as needed, or as directed by a doctor. Do not take more than 24 tablets in 24 hours.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, stearic acid

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: sodium 178 mg
  • for institutional use only
  • store at room temperature 15˚ - 30˚C (59˚ - 86˚F)

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hsthst

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-676-01EA - Each57896-676428e9400-684b-41e3-a24a-a806a0bc1be712018-06-11
57896-676-10EA - Each57896-67688890751-dad3-460d-ad91-311d2ed3299e12018-01-12

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-67657896-676-10, 57896-676-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
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
08789c31-38df-50d6-e063-6294a90a152361421283-27bd-265e-e053-2991aa0a5cce2023-10-24WarningsExact identifier
spl set id: 61421283-27bd-265e-e053-2991aa0a5cce

Reported adverse events (FAERS/openFDA)#

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