FDA.reportPublic FDA data

INON

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:17

Label at a glance#

ProductINON
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients [in each packet (1.92g)]
Aluminum hydroxide 400 mg
Magnesium carbonate 400 mg
Sodium bicarbonate 700 mg

OTC - PURPOSE SECTION

Purpose
Aluminum hydroxide     Antacid
Magnesium carbonate     Antacid
Sodium bicarbonate     Antacid

INDICATIONS & USAGE SECTION

Uses relieves these symptoms
■ heartburn    ■ sour stomach    ■ acid indigestion

WARNINGS SECTION

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - WHEN USING SECTION

When using this product

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

■ May have laxative effect


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 - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
■ Adults and children 12 years of age and over: Take 1 packet at a time 3 times daily between meals or after meals, or as directed by a doctor
■ Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information ■ Each packet contains: sodium 175 mg, magnesium 95 mg

INACTIVE INGREDIENT SECTION

Inactive ingredients  colloidal silicon dioxide, flavor, partially hydrolyzed polyvinyl alcohol, sugar, starch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

inongrancart.jpg cartoncarton


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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-045-01INON1.92 g in 1 PACKETGRANULE1.924
49873-045-01INON12 in 1 CARTONGRANULE124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-045INON (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) GRANULE [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231205_e86d9c57-c877-49f1-a405-95a9a226ccf3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN01
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NA1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN01
bicarbonate ionACTIVE MOIETYHN1ZRA3Q201
carbonate ionACTIVE MOIETY7UJQ5OPE7D1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9901
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3T1
SUCROSEINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-04549873-045-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYVINYL ALCOHOL532B59J990IACT
SUCROSEC151H8M554IACT
STARCH, POTATO8I089SAH3TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SUSPENSION / ORAL5 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii+route
14 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route
14 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990CAPSULE / ORAL1.67 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SUSPENSION / ORAL5 mgExact identifier — unii+route
14 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii+route
14 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET / ORAL458 mgExact identifier — unii+route
6 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET, COATED / ORAL1.37 mgExact identifier — unii+route
6 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET / ORAL458 mgExact identifier — unii+route
6 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii+route
14 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990CAPSULE / ORAL1.67 mgExact identifier — unii+route
14 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET, COATED / ORAL1.37 mgExact identifier — unii+route
6 equally ranked IID candidates

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
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
ndc (package): 49873-045-01
ndc (product): 49873-045
ndc11 (package): 49873004501
spl id: 0bb8901e-89d2-b026-e063-6294a90ae77a
spl set id: e86d9c57-c877-49f1-a405-95a9a226ccf3

Reported adverse events (FAERS/openFDA)#

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