OTC - ACTIVE INGREDIENT SECTION
Corn sterilized quantitative extract (beta sitosterol)
Corn sterilized quantitative extract (beta sitosterol)
Periodontal disease [Dental caries disease, gingivitis, periodontitis (periodontal periodontitis)]
Keep out of reach of children
■ adult: two tablets once, three times a day before meal
■ as a maintenance dose, one tablet once, three times a day before meal
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
magnesium stearate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, povidone K30
For oral use only
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73442-0002-1 | 2025-02-12 | C162847 | 48780-1 | 2cef2736-5d95-d83d-e063-dadaa90ab31f | 96e0edae-dbe7-50e8-e053-2995a90ac68a |
| 73442-0002-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5d95-d83d-e063-dadaa90ab31f | 96e0edae-dbe7-50e8-e053-2995a90ac68a |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73442-0002 | INSADOL (CORN STERILIZED QUANTITATIVE EXTRACT (BETA SITOSTEROL)) TABLET [I WORLD PHARMACEUTICAL CO., LTD.] | 2 | Legacy NDC | 20250215_96e0edae-dbe7-50e8-e053-2995a90ac68a.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73442-0002 | 73442-0002-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| .BETA.-SITOSTEROL | S347WMO6M4 | ACTIB |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 368fe909-db2f-a065-e063-6294a90acd51 | 96e0edae-dbe7-50e8-e053-2995a90ac68a | 2025-06-02 | Warnings | 96e0edae-dbe7-50e8-e053-2995a90ac68a |
Adverse event summaries are temporarily unavailable. Other product information remains available.