Insadol
FDA Label NDC 72988-0016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lydia Co., Ltd for the product Insadol (NDC 72988-0016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

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

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

Warnings

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

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

Dosage & Administration

For oral use only

Package Label.Principal Display Panel

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