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 |
|---|---|---|---|---|---|
| 72988-0016-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-336f-a910-e053-dadaa90a0b85 | 945bd5ac-088d-06f1-e053-2a95a90a33ff |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72988-0016-1 | INSADOL | 100 in 1 BLISTER PACK | TABLET | 100 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72988-0016 | INSADOL (CORN STERILIZED QUANTITATIVE EXTRACT (BETA SITOSTEROL)) TABLET [LYDIA CO., LTD] | 1 | Legacy NDC, 1 package rows | 20191008_945bd5ac-088d-06f1-e053-2a95a90a33ff.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72988-0016 | 72988-0016-1 |
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 |
|---|---|---|---|---|---|---|
| 945bd5ac-088f-06f1-e053-2a95a90a33ff | 945bd5ac-088d-06f1-e053-2a95a90a33ff | 2019-10-07 | Warnings | 945bd5ac-088f-06f1-e053-2a95a90a33ff 945bd5ac-088d-06f1-e053-2a95a90a33ff |
Adverse event summaries are temporarily unavailable. Other product information remains available.