FDA.reportPublic FDA data

Sodium Bicarbonate Antacid - NCS HealthCare of KY, LLC dba Vangard Labs

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:10:21

Label at a glance#

ProductSodium Bicarbonate Antacid
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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

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

Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 yeasr of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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 doctor if symptoms last more than 2 weeks

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 out of reach of children.

OVERDOSAGE SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

​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

OTHER SAFETY INFORMATION

  • each tablet contains: sodium 178 mg
  • store in a dry place at 15° – 30°C (59° – 86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, microcrystalline cellulose, silica, stearic acid, talc.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING

LEAD, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND

BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. FOR MORE INFORMATION

GO TO WWW.P65WARNINGS.CA.GOV.

Rev. 10/22 R-29

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1280536104710sodium-bicarbonate-tabs-8641-1.jpg
Data codeCode 128053610471039sodium-bicarbonate-tabs-8641-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1047-10EA - Each0536-1047fe82f6ce-ce8f-4ece-9ce3-f295a564ef9812015-06-09

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-86410615-8641-39
0536-1047

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT

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 AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsExact identifier
ndc (package): 0615-8641-39
ndc (product): 0615-8641
ndc11 (package): 00615864139
spl id: bda92f22-0c50-4105-b1fb-c4eb5c12678d
spl set id: fde4ea0c-152b-4b79-a6d8-2b0dbd9107aa

Reported adverse events (FAERS/openFDA)#

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