Stona-S

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Stona-S
Generic name
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
Sato Pharmaceutical Co., Ltd.
Product type
HUMAN OTC DRUG
SPL set ID
2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1
SPL ID
0bb87850-ad34-ce89-e063-6294a90a421d
Version
8
Effective date
2023-12-04
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:24:07
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■more than 12 capsules in 24 hours, which is the maximum daily amount for this product ■with other drugs containing acetaminophen ■3 or more alcoholic drinks everyday while using this product Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease). If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist. ■ for 2 weeks after stopping the MAOI drug Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ diabetes ■ thyroid disease ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are ■taking the blood thinning drug warfarin ■taking sedatives or tranquilizers When using this product ■do not exceed recommended dosage ■may cause excitability especially in children ■do not drive or operate machinery ■avoid alcoholic beverages ■may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days sore throat persists for more than 2 days nervousness, dizziness, or sleeplessness occur any of the following occurs (these could be signs of a serious condition): fever gets worse or or lasts more than 3 days a severe sore throat sore throat is accompanied or followed by high fever, headache, rash, nausea or vomiting redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts Do not give to children under 12 years of age unless directed by a doctor. 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.