STONA COUGH- dextromethorphan hydrobromide, guaifenesin syrup 
Sato Pharmaceutical Co., Ltd.

----------

Stona Cough Syrup

Active ingredients (in 10 mL)
Dextromethorphan hydrobromide 30 mg
Guaifenesin 200 mg

Purpose
Dextromethorphan hydrobromide    Cough suppressant
Guaifenesin    Expectorant

Uses
For the temporary relief of cough due to the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS

Enter section text here

Do not use this product

■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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

■for a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

■if cough is accompanied by excessive phlegm (mucos) unless directed by a doctor.

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.

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

If pregnant or breast-feeding, ask a health professional before use.

Directions
■Adults and children 12 years of age and over: Take 10mL every 6 – 8 hours, not to exceed 30mL in 24 hours, or as directed by a doctor.
■Children under 12 years: Ask a doctor.

Inactive ingredients
alcohol, beta-cyclodextrin, butylparaben, calcium chloride, caramel, citric acid, flavor, glycyrrhiza (licorice) extract, propylparaben, sodium benzoate, sodium saccharin, sugar, water.

stonacoughsyrcartA.jpg Carton, panels 1, 2

stonacoughsyrcartB.jpg Carton, panels 3, 4

STONA COUGH 
dextromethorphan hydrobromide, guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BETADEX (UNII: JV039JZZ3A)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CARAMEL (UNII: T9D99G2B1R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry brandy) , VANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-302-011 in 1 CARTON01/03/2001
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/03/2001
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-302) , label(49873-302) , pack(49873-302)

Revised: 11/2023
Document Id: 09fb9b1c-b0c7-95a9-e063-6394a90a51db
Set id: 0b638db4-5ed3-4665-abcd-f95e677adbd8
Version: 4
Effective Time: 20231112
 
Sato Pharmaceutical Co., Ltd.