STONA- dextromethorphan hydrobromide lozenge 
Sato Pharmaceutical Co., Ltd.

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Stona Troche

Active ingredients (in each lozenge)
Dextromethorphan HBr 10mg

Purpose
Cough suppressant

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 out 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.

stonatrochecart.jpg Stona Troche Carton

STONA 
dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
LICORICE (UNII: 61ZBX54883)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SUCROSE (UNII: C151H8M554)  
ASPARTAME (UNII: Z0H242BBR1)  
Product Characteristics
Colorbrown (pale brown) Scoreno score
ShapeROUNDSize14mm
FlavorBLUEBERRY, GRAPEImprint Code SATO;SATO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-301-011 in 1 CARTON11/19/1995
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/19/1995
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-301) , label(49873-301) , pack(49873-301)

Revised: 11/2023
Document Id: 0b3fbae8-f6b3-d405-e063-6394a90adecd
Set id: 1ccc9e56-32a4-450f-8412-5814b6aef285
Version: 6
Effective Time: 20231128
 
Sato Pharmaceutical Co., Ltd.