Stona

DEXTROMETHORPHAN HYDROBROMIDE ORAL HUMAN OTC DRUG

Stona is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE 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 20231128.

Generic name
DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
Sato Pharmaceutical Co., Ltd.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
49873-301
Application
M012
Label effective
20231128

Active ingredients

Active ingredients (in each lozenge) Dextromethorphan HBr 10mg

Indications & Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation associated with ■a cold ■inhaled irritants

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

Contraindications

Not available.

Warnings

Enter section text here 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. 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. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Not available.

More products with the same ingredient

DEXTROMETHORPHAN HYDROBROMIDE

TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM

AptaPharma Inc. View label