Otc - Active Ingredient
Liriope Tuber 3.33g
PinelliaTuber 1.67g
Jujube 1.00g
Han Shin Maekdam Extract Granules Granule
FDA Label NDC 73466-0032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Misocos for the product Han Shin Maekdam Extract Granules (NDC 73466-0032). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, 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
Inactive Ingredient
corn starch, Lactose Hydrate
Otc - Purpose
■Cough with a sticky sputum ■Bronchitis ■Bonchial asthma
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
■ Take a packet of medicine (one dose) of an adult three times a day before or between meals.
Warnings
Warnings
When using this product
■Do not use in patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption since this drug contains lactose.
■Do not use it for more than 1 month unless the symptoms improve.
■Long-term use should only be done under medical supervision.
■When used in combination with potassium-containing agents, licorice-containing drugs, and diuretics (e.g., furosemide, ethacrynic acid, trichlormethiazide), myopathy is likely to occur, so take it carefully.
Ask a doctor before use if you have high blood pressure, edema, sputum, heart or kidney problems, another disease.
Stop use and ask a doctor if the following serious side effects occur. These may be signs of a serious condition.
■Gastric aldosteronism (decreased urine, swollen face, hands, feet, eyelids, etc.)
■Myopathy (muscle weakness, cramps, paralysis)
■Interstitial pneumonia (fever, cough, shortness of breath, lung sound abnormalities)
■Liver disorders (elevated liver enzymes, jaundice)
■Skin reactions (rash, hives)
■Digestive issues (loss of appetite, stomach discomfort)
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away
Dosage & Administration
for oral use only
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
