FDA Label for Stona
View Indications, Usage & Precautions
Stona Product Label
The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each lozenge)
Dextromethorphan HBr 10mg
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
Enter section text here
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
stonatrochePDP.jpg
stonatrochecart.jpg
* Please review the disclaimer below.