FDA.reportPublic FDA data

Inon Ace Solution

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:03:29

Label at a glance#

ProductInon Ace
Active ingredientSILODRATE, MAGNESIUM HYDROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each bottle)
Magnesium Aluminosilicate 900 mg
Magnesium Hydroxide 250 mg

OTC - PURPOSE SECTION

Purpose
Magnesium Aluminosilicate     Antacid
Magnesium Hydroxide     Antacid

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use this product if you are taking a prescription antibiotic drug containing any
form of tetracycline.

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product
■ do not take more than 2 bottles (adults and children 12 years and over) 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.
■ may have a laxative effect.

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.

DOSAGE & ADMINISTRATION SECTION

Directions
■ adults and children 12 years and over: Take 1 bottle (30mL) at a time 2 times daily,    
    between meals, or as directed by a doctor.
■ children under 12 years: Ask a doctor.
■ shake well before use.

OTHER SAFETY INFORMATION

Other information
■ each bottle contains: sodium 15 mg, magnesium 165 mg

INACTIVE INGREDIENT SECTION

Inactive ingredients  alcohol, butylparaben, citric acid, flavors (cinnamon oil, fluid
extract of ginger root, spearmint oil), hydroxypropylstarch, PEG-60 hydrogenated castor
oil, propylparaben, sodium benzoate, sodium citrate, sorbitol, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1246297aluminum magnesium silicate 900 MG / magnesium hydroxide 250 MG in 30 mL Oral SolutionPSN7
1246303Inon Ace 900 MG / 250 MG in 30 mL Oral SolutionPSN7
1246303aluminum magnesium silicate 30 MG/ML / magnesium hydroxide 8.33 MG/ML Oral Solution [Inon Ace Solution]SBD7
1246297aluminum magnesium silicate 30 MG/ML / magnesium hydroxide 8.33 MG/ML Oral SolutionSCD7
1246303Inon Ace Solution (aluminum magnesium silicate 30 MG/ML / magnesium hydroxide 8.33 MG/ML) Oral SolutionSY7
1246303Inon Ace Solution (aluminum magnesium silicate 900 MG / magnesium hydroxide 250 MG) per 30 ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-403-01Inon Ace2 in 1 CARTONSOLUTION27
49873-403-01Inon Ace30 mL in 1 BOTTLESOLUTION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-403INON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]7Current NDC, Legacy NDC, 2 package rows20231207_a6e4475c-dfac-493c-b98a-21473e3b59d5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S3
SILODRATEACTIVE INGREDIENT9T3UU8T0QK3
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8383
SILODRATEACTIVE MOIETY9T3UU8T0QK3
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV83
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)INACTIVE INGREDIENT9M44R3409A3
POLYOXYL 60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQG3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR3
SORBITOLINACTIVE INGREDIENT506T60A25R3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
49873-40349873-403-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BUTYLPARABEN3QPI1U3FV8IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT
POLYOXYL 60 HYDROGENATED CASTOR OIL02NG325BQGIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SILODRATE9T3UU8T0QKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYOXYL 60 HYDROGENATED CASTOR OILPEG-60 HYDROGENATED CASTOR OIL02NG325BQGGEL / TOPICAL352 mgExact identifier — unii candidate
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYOXYL 60 HYDROGENATED CASTOR OILPEG-60 HYDROGENATED CASTOR OIL02NG325BQGINJECTION / INTRAVENOUS20 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYOXYL 60 HYDROGENATED CASTOR OILPEG-60 HYDROGENATED CASTOR OIL02NG325BQGGEL / TOPICAL352 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYOXYL 60 HYDROGENATED CASTOR OILPEG-60 HYDROGENATED CASTOR OIL02NG325BQGINJECTION / INTRAVENOUS20 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYOXYL 60 HYDROGENATED CASTOR OILPEG-60 HYDROGENATED CASTOR OIL02NG325BQGCREAM / TOPICAL1.9 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYOXYL 60 HYDROGENATED CASTOR OILPEG-60 HYDROGENATED CASTOR OIL02NG325BQGCREAM / TOPICAL1.9 %w/wExact identifier — unii candidate
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
Inon AceMAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDESato Pharmaceutical Co., Ltd.a6e4475c-dfac-493c-b98a-21473e3b59d52023-12-06WarningsExact identifier
ndc (package): 49873-403-01
ndc (product): 49873-403
ndc11 (package): 49873040301
spl id: 0bde7bd2-8a69-57b4-e063-6394a90a00d2
spl set id: a6e4475c-dfac-493c-b98a-21473e3b59d5

Reported adverse events (FAERS/openFDA)#

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