Otc - Active Ingredient
Active ingredients (in 10 mL)
Dextromethorphan hydrobromide 30 mg
Guaifenesin 200 mg
Stona Cough Syrup
FDA Label NDC 49873-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Stona Cough (NDC 49873-302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, precautions, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Dextromethorphan hydrobromide Cough suppressant
Guaifenesin Expectorant
Indications & Usage
Uses
For the temporary relief of cough due to the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Warnings
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Otc - Do Not Use
Do not use this product
■if you are 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
■for a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
■if cough is accompanied by excessive phlegm (mucos) unless directed by a doctor.
Precautions
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep our of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions
■Adults and children 12 years of age and over: Take 10mL every 6 – 8 hours, not to exceed 30mL in 24 hours, or as directed by a doctor.
■Children under 12 years: Ask a doctor.
Inactive Ingredient
Inactive ingredients
alcohol, beta-cyclodextrin, butylparaben, calcium chloride, caramel, citric acid, flavor, glycyrrhiza (licorice) extract, propylparaben, sodium benzoate, sodium saccharin, sugar, water.
Package Label.Principal Display Panel
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Carton, Panels 1, 2 (Stonacoughsyrcarta)
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Carton, Panels 3, 4 (Stonacoughsyrcartb)
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