INSADOL (corn sterilized quantitative extract- beta sitosterol tablet

INSADOL by

Drug Labeling and Warnings

INSADOL by is a Otc medication manufactured, distributed, or labeled by LYDIA Co., Ltd, I World Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Corn sterilized quantitative extract (beta sitosterol)

PURPOSE

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSADOL 
corn sterilized quantitative extract (beta sitosterol) tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72988-0016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4)	.BETA.-SITOSTEROL	35 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ISD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72988-0016-1	100 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/08/2019

Labeler - LYDIA Co., Ltd (695735569)

Registrant - LYDIA Co., Ltd (695735569)

Establishment
Name	Address	ID/FEI	Business Operations
I World Pharmaceutical Co., Ltd		688222857	manufacture(72988-0016)

Establishment
Name	Address	ID/FEI	Business Operations
LYDIA Co., Ltd		695735569	label(72988-0016)