Stona for Children

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 for Children
Generic name
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
Sato Pharmaceutical Co., Ltd.
Product type
HUMAN OTC DRUG
SPL set ID
18f3d694-9dff-407e-a264-916dbd201f9a
SPL ID
57efcfb1-045c-d6c7-e063-6394a90a843b
Version
7
Effective date
2026-07-31
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:18:25
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 your child takes: more than 5 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 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 your child is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma liver disease Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not exceed recommended dosage may cause excitability in children may cause marked drowsiness sedatives and tranquilizers may increase the drowsiness effect Stop use and ask a doctor if ■pain or cough gets worse or lasts more than 5 days ■fever gets worse or lasts more than 3 days ■redness or swelling is present ■new symptoms occur ■cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. 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 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.