Stona for Children

Stona for Children is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by Sato Pharmaceutical Co., Ltd. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 49873-108, application M012, label effective 20260731. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: temporary relief, following cold, symptoms minor, pains headache, sneezing runny, nose cough, bronchial irritation, temporarily reduces. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of the following cold symptoms minor aches and pains headache sneezing runny nose cough due to minor throat and bronchial irritation temporarily reduces fever

Directions do not take more than 5 doses in any 24 hour period use only with enclosed measuring cup dose as follows while symptoms persist, or as directed by a doctor children 6 to under 12 years of age: Take 15 mL every 4 hours children under 6 years of age: do not use. ask a doctor. ​This product does not contain directions or complete warnings for adult use

​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.

FDA lists 2 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Stona for Children used for?
Uses For the temporary relief of the following cold symptoms minor aches and pains headache sneezing runny nose cough due to minor throat and bronchial irritation temporarily reduces fever

Who makes Stona for Children?
Sato Pharmaceutical Co., Ltd. is the labeler of record for Stona for Children. 2 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Stona for Children come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Stona for Children prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE?
Yes. 2 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Stona for Children been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.