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Stona

Sato Pharmaceutical Co., Ltd.

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each lozenge)
Dextromethorphan HBr 10mg

Purpose

Purpose
Cough suppressant

Uses

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

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 our of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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 information  
■Phenylketonurics: Contains Phenylalanine (18.3mg) per lozenge.

Inactive ingredients  aspartame, cetylpyridinium chloride, flavor, glycyrrhiza, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, sucrose.

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stonatrochecart.jpgStona

Stona

dextromethorphan hydrobromide LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-301
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
cetylpyridinium chloride
LICORICE
hydroxypropyl cellulose
SILICON DIOXIDE
MAGNESIUM STEARATE
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
brown (pale brown) 14 mm SATO;SATO ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:49873-301-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1995-11-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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