Stona-S

Stona-S is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE. It is labelled by Sato Pharmaceutical Co., Ltd. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 49873-113, application M012, label effective 20231204. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE. 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, PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: hay fever, temporarily relieves, symptoms due, minor aches, pains headache, sore throat, nasal congestion, runny nose. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ■temporarily relieves these symptoms due to a cold, the flu, or hay fever: ■minor aches and pains ■headache ■sore throat ■nasal congestion ■runny nose ■sinus congestion and pressure ■cough due to minor throat and bronchial irritation ■sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■temporarily reduces fever

Directions ■adults and children 12 years of age and older: 2 capsules every 4 hours, while symptoms persist, not to exceed 6 doses (12 capsules) in 24 hours, or as directed by a doctor ■children under 12 years of age: ask a doctor

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.

FDA lists 3 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 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-S used for?
Uses ■temporarily relieves these symptoms due to a cold, the flu, or hay fever: ■minor aches and pains ■headache ■sore throat ■nasal congestion ■runny nose ■sinus congestion and pressure ■cough due to minor throat and bronchial irritation ■sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■temporarily reduces fever

Who makes Stona-S?
Sato Pharmaceutical Co., Ltd. is the labeler of record for Stona-S. 3 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, 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-S 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-S 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, PHENYLEPHRINE HYDROCHLORIDE?
Yes. 3 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 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-S 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.