The following Structured Product Label (SPL) was submitted to the FDA by Medicarebio.co.ltd for the product Stomasin (NDC 82871-301). 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 active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Gypsum fibrosum extract, Forsythia viridissima fruit extract, Arctium lappa fruit extract, Platycodon grandiflorus root extract, Saposhnikovia divaricata root extract, Glycyrrhiza uralensis root extract, Ostericum koreanum extract, Schizonepeta tenuifolia extract
antipyretic, anti-inflammatory, anti-corona virus (omicron variant)
for swelling and sore throat symptoms
temporarily reduces fever; relieves swelling and sore throat for tonsillitis / peritonsillitis
Do not use in the following patients
Because this drug contains lactose, it should not be administered to patients with genetic problems such as galactose intolerance, lactose intolerance, or glucose-galactose malabsorption.: See Insert Paper
Keep out of reach of children
In the following cases, stop using this drug immediately and consult a doctor, carry this Insert Paper with you. : See Insert Paper
The following people should not use this drug. Infants under 3 months
The following people should consult with a doctor before use if you have .: See Insert Paper
Storage precautions : See Insert Paper
If pregnant or breast-feeding, ask a health professional before use
In case of overdose, get medical help or contact a Poison Control Center immediately
Adults Take 2 capsules per time, 3 times a day
Children 7 years to under 14 years 2/3 of the adult dose (4/3 capsules)
Children 4 years to under 6 years 1/2 of the adult dose (1 capsule)
Children 2 years to under 3 years 1/3 of the adult dose (2/3 capsule)
Children under 1 years 1/4 of the adult dose (1/2 capsule)
Dissolve it in lukewarm water before or between meals (between meals and between meals) and take it slowly in small portions while moistening the mouth or throat (do not swallow capsules).
protect from excessive moisture, store at 1~30℃(33.8~86℉)
FD&C blue no.1, FD&C blue no.3, FD&C yellow no.5, lactose hydrate (cow, milk), magnesium stearate, silicon dioxide, gelatin
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