Sodium Bicarbonate 10 gr. (650 mg) - Gendose Pharmaceuticals, LLC

Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2026-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:32

Label at a glance#

ProductSodium Bicarbonate 10 gr. (650 mg)
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: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

Storage and handling

each tablet contains: sodium 178 mg (7.74 mEq) store at room temperature 15º-30ºC (59º-86°F)

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 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. 

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have a sodium restricted diet.

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

OTC - STOP USE SECTION

Stop use and ask a doctorif symptoms last more than 2 weeks.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, 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  (1-800-222-1222) immediately.

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: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
  • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:sodium 178 mg (7.74 mEq)
  • store at room temperature 15º-30ºC (59º-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-676-7161

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN1
198861sodium bicarbonate 650 MG Oral TabletSCD1
198861NaHCO3 650 MG Oral TabletSY1
198861sodium bicarbonate 10 Grains Oral TabletSY1
198861sodium bicarbonate 648 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Omni(01)00377333829104GTIN-14: 00377333829104
GTIN-12: 377333829104
UPC-A: 377333829104
EAN-13: 0377333829104
GTIN storage (14 digits): 00377333829104
label.jpg

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
77333-829-10Sodium Bicarbonate 10 gr. (650 mg)100 in 1 BOX, UNIT-DOSETABLET1001
77333-829-25Sodium Bicarbonate 10 gr. (650 mg)10 in 1 BLISTER PACKTABLET101

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
77333-82977333-829-25, 77333-829-10

Ingredients#

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

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

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 Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
ndc (package): 77333-829-25
ndc (package): 77333-829-10
ndc (product): 77333-829
ndc11 (package): 77333082910
ndc11 (package): 77333082925
spl id: 4f52483b-6426-9646-e063-6394a90a5c0b
spl set id: 0a0cc46d-372e-4175-932a-065e82d8d353

Reported adverse events (FAERS/openFDA)#

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