Stona Cough
Stona Cough is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE manufactured by Sato Pharmaceutical Co., Ltd. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231204.
Generic: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: Sato Pharmaceutical Co., Ltd.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 49873-306
Application: M012
Effective: 20231204
Active Ingredients: Active ingredients (in each tablet) Dextromethorphan hydrobromide 15mg Guaifenesin 100 mg Phenylephrine hydrochloride 5 mg
Indications & Usage
Uses ■ for the temporary relief of cough and nasal congestion due to the common cold ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Dosage & Administration
Directions adults and children 12 years of age and over: take 2 tablets every 6 to 8 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: take 1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor children under 6 years of age: ask a doctor
Contraindications
Not available.
Warnings
Warnings Do not use ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) ■ for 2 weeks after the stopping the MAOI drug Ask a doctor before use if you have ■ heart disease ■ thyroid disease ■ high blood pressure ■ high fever ■ diabetes ■ difficulty in urination due to enlarged prostate gland ■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are ■ taking a prescription drug and do not know if it contains an MAOI When using this product ■ do not exceed recommended dosage Stop use and ask a doctor if ■ symptoms persist for more than 1 week or cough tends to recur (a persistent cough may be sign of a serious condition) ■ nervousness, dizziness, or sleeplessness occur ■ cough is accompanied by rash or persistent headache ■ symptoms are accompanied by fever 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.
Adverse Reactions
Not available.
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