FDA.reportPublic FDA data

Sodium Bicarbonate - TWIN MED LLC

Manufacturer
TWIN MED LLC
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:41

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

Adults:  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 store at room temperature 15-30ºC (59-86°F) in well-closed containers 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 doctor. 

OTC - ASK DOCTOR SECTION

Stop use and ask a doctorifsymptoms last more than 2 weeks.

SPL UNCLASSIFIED SECTION

Stomach Warning: TO AVOID SERIOUS INJURY, D0 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.

SPL UNCLASSIFIED SECTION

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

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 THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: 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
  • store at room temperature 15-30ºC (59-86°F) in well-closed containers as defined in the USP

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, and Stearic Acid

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-844-912-4012

PRINCIPAL DISPLAY PANEL - 1000 Tablets Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN2
198861sodium bicarbonate 650 MG Oral TabletSCD2
198861NaHCO3 650 MG Oral TabletSY2
198861sodium bicarbonate 10 Grains Oral TabletSY2
198861sodium bicarbonate 648 MG Oral TabletSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-332-10Sodium Bicarbonate1000 in 1 BOTTLETABLET10002

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-33255681-332-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
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 BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
ndc (package): 55681-332-10
ndc (product): 55681-332
ndc11 (package): 55681033210
spl id: 50c437cb-e5c2-0e2b-e063-6394a90a3e2b
spl set id: 0f867f56-4bc0-4a85-b9d2-a16282b7c82b

Reported adverse events (FAERS/openFDA)#

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