FDA.reportPublic FDA data

OHTAS ISAN ANTACID

Manufacturer
OHTA'S ISAN CO.,LTD.
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:28:03

Label at a glance#

ProductOHTAS ISAN ANTACID
Active ingredientCALCIUM CARBONATE, SODIUM BICARBONATE
Label structure11 sections

Indications and uses

relieves: heartburn sour stomach acid indigestion upset stomach due to these symptoms

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each packet )

OTC - ACTIVE INGREDIENT SECTION

Precipitated calcium carbonate 497 mg

Sodium bicarbonate 600 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not take more than 3 packets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

Ask a doctor of a pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • on a sodium-restricted diet.

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.

Direction

DOSAGE & ADMINISTRATION SECTION

take 1 packet with water, 3 times daily, or as directed by a physician.

Other information

OTHER SAFETY INFORMATION

each packet contains: sodium 164 mg.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cinnamon bark, citrus unshiu peel, clove, fennel, gentian, l-menthol, magnesium carbonate, nutmeg, powdered picrasma wood.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – 16 Packets Box Label

NDC 49631-178-13

Graphic – Ohta's Isan Logo

Ohta's Isan ANTACID POWDER

Heartburn Herb Flavored

Acid Upset

Indigestion Stomach

OHTA'S ISAN MADE IN JAPAN 16 Packets

Principal Display Panel – 16 Packets Box Label
Principal Display Panel – 16 Packets Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1361708calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral PowderPSN4
1361708calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral PowderSCD4
1361708Calcium Carbonate 497 MG / NaHCO3 600 MG Oral PowderSY4

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
49631-178-13OHTAS ISAN ANTACID1 in 1 BOXPOWDER14
49631-178-13OHTAS ISAN ANTACID16 in 1 DOSE PACKPOWDER164

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49631-178OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO.,LTD.]4Current NDC, Legacy NDC, 2 package rows20241023_8723fe90-8402-4511-b6c6-b71cf98513e3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49631-17849631-178-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CINNAMON5S29HWU6QBIACT
TANGERINEKH3E3096OOIACT
CLOVEK48IKT5321IACT
FENNEL557II4LLC3IACT
GENTIANA LUTEA ROOTS72O3284MSIACT
LEVOMENTHOLBZ1R15MTK7IACT
NUTMEGAEE24M3MQ9IACT
PICRASMA QUASSIOIDES WOOD75EIV4LX7WIACT
MAGNESIUM CARBONATE0E53J927NAIACT
CALCIUM CARBONATEH0G9379FGKACTIB
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
ndc (product): 49631-178
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
ndc (package): 49631-178-13
ndc (product): 49631-178
ndc11 (package): 49631017813
spl id: 24c5b10a-a217-7bae-e063-6394a90aaf4c
spl set id: 8723fe90-8402-4511-b6c6-b71cf98513e3

Reported adverse events (FAERS/openFDA)#

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