INSADOL

Manufacturer
LYDIA Co., Ltd | I World Pharmaceutical Co., Ltd
Effective date
2019-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:45

Label at a glance#

ProductINSADOL
Active ingredient.BETA.-SITOSTEROL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Corn sterilized quantitative extract (beta sitosterol)

OTC - PURPOSE SECTION

Periodontal disease [Dental caries disease, gingivitis, periodontitis (periodontal periodontitis)]

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

■ adult: two tablets once, three times a day before meal

■ as a maintenance dose, one tablet once, three times a day before meal

WARNINGS SECTION

Do not take this medicine if

■ people who are hypersensitive to the drugs and ingredients contained in this medicine

Consult a doctor, dentist, or pharmacist before taking this medicine

■ Patients who are overreacting to substrates of azoic pigment, acetyl salicylic acid or other prostaglandin syncase inhibitors should be careful about the use of this drug ■ Be careful because this drug may interfere with the absorption of cholesterol medicines.

■ Pregnancy and lactation (for pregnant women or wives who are likely to be pregnant, only if the therapeutic benefit exceeds the risk) ■ Since this drug contains yellow 4 (tartrazine), consult a doctor, dentist, or pharmacist before taking it (for that item only)

Immediately stop taking this medicine and consult a doctor or pharmacist if: ■ the drug is administered to patients with asthma or chronic stomatosis or is overreacting to non-steroidal anti-inflammatory drugs, it may cause anaphylaxis or respiratory system to overreact

INACTIVE INGREDIENT SECTION

magnesium stearate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, povidone K30

DOSAGE & ADMINISTRATION SECTION

For oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2104173beta sitosterol 35 MG Oral TabletPSN1
2104173beta sitosterol 35 MG Oral TabletSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72988-0016-12021-01-29C16284748780-1ba0f9c33-336f-a910-e053-dadaa90a0b85945bd5ac-088d-06f1-e053-2a95a90a33ff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0016-1INSADOL100 in 1 BLISTER PACKTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0016INSADOL (CORN STERILIZED QUANTITATIVE EXTRACT (BETA SITOSTEROL)) TABLET [LYDIA CO., LTD]1Legacy NDC, 1 package rows20191008_945bd5ac-088d-06f1-e053-2a95a90a33ff.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-001672988-0016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
945bd5ac-088f-06f1-e053-2a95a90a33ff945bd5ac-088d-06f1-e053-2a95a90a33ff2019-10-07WarningsExact identifier
spl id: 945bd5ac-088f-06f1-e053-2a95a90a33ff
spl set id: 945bd5ac-088d-06f1-e053-2a95a90a33ff

Reported adverse events (FAERS/openFDA)#

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