Otc - Active Ingredient
Dry Ginger 1.90g
Glycyrrhiza 1.90g
Peony Root 1.90g
Han Shin Gamkonal Extract Granules Granule
FDA Label NDC 73466-0033
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 Gamkonal Extract Granules (NDC 73466-0033). 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
■Bronchitis, Bronchial asthma, Coryza, Runny nose, Cough with dilute phlegm, rhinitis
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.
■When combined with MaHuang or ephedrine-containing agents, MAO inhibitors, thyroid agents(thyroxine, liothyronine), catecholamine agents(epinephrine, isoprenaline), and xanthin agents(theophylline, dipropylene), symptoms such as insomnia, excessive sweat, rapid pulse, frequent urination, palpitations, general weakness, and mental excitement are likely to appear, so take them carefully.
Ask a doctor before use if you have high blood pressure, edema, heart or kidney problems, rash, redness, diabetic, 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
* Please review the disclaimer below.
