Otc - Active Ingredient
Active ingredients (in each lozenge)
Dextromethorphan HBr 10mg
Stona Lozenge
FDA Label NDC 49873-301
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 (NDC 49873-301). 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, otc - ask doctor/pharmacist, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Cough suppressant
Indications & Usage
Uses temporarily relieves cough due to minor throat and bronchial irritation associated with
■a cold ■inhaled irritants
Warnings
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Otc - Do Not Use
Do not use
■this product for persistent or chronic cough such as occurs with smoking, asthema, or emphysem, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use 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 you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Dosage & Administration
Directions
Adults and children 12 years and older - Let 1 or 2 lozenges dissolve slowly in the mouth every 4 hours, not more than 12 lozenges in 24 hours.
Children 6 years to under 12 years - Let 1 lozenge dissolve slowly in the mouth every 4 hours, not more than 6 lozenges in 24 hours.
Children under 6 years - Ask a doctor
■once or twice daily, preferably morning and evening, when needed or as directed by a doctor
■start initial dosage with minimum dose, then adjust it to suit to bowel condition
Other Safety Information
Other information
■Phenylketonurics: Contains Phenylalanine (18.3mg) per lozenge.
Inactive Ingredient
Inactive ingredients aspartame, cetylpyridinium chloride, flavor, glycyrrhiza, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, sucrose.
Package Label.Principal Display Panel
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Stona Troche Carton (Stonatrochecart)
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