FDA.reportPublic FDA data

Sodium Bicarbonate

Manufacturer
TWIN MED LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2025-07-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:36:14

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

Take 1 tablet, dissolved in a glass of water, as needed. Maximum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking. DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Storage and handling

each tablet contains: sodium 178 mg (7.74 mEq) store at room temperature 15º-30ºC (59º-86°F) in a well-closed container as defined in the USP

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sodium Bicarbonate 10 gr (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

OTC - DO NOT USE SECTION

Do not usethis product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

Stomach Warning

SPL UNCLASSIFIED SECTION

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

Consult a doctor if severe stomach pain occurs after taking this product.

Drug Interaction Precaution

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults

SPL UNCLASSIFIED SECTION

Take 1 tablet, dissolved in a glass of water, as needed. Maximum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.

DO NOT EXCEED RECOMMENDED DOSE.Not recommended for children.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 178 mg (7.74 mEq)
  • store at room temperature 15º-30ºC (59º-86°F) in a well-closed container as defined in the USP

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline cellulose and stearic acid, magnesium stearate

Questions or comments?

OTC - QUESTIONS SECTION

Questions ? call toll-free 1-844-912-4012

PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55681-331-10

Sodium Bicarbonate

Tablets, USP

10 gr (650 mg)

ANTACID

BICARBBICARB

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
55681-33155681-331-10

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
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM BICARBONATE8MDF5V39QOACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
47d98aa1-5722-f97c-e063-6394a90a5a40f7f1bec4-452f-8fdc-e053-6294a90a39892026-01-07WarningsExact identifier
spl set id: f7f1bec4-452f-8fdc-e053-6294a90a3989

Reported adverse events (FAERS/openFDA)#

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