Label: STONA COUGH- dextromethorphan hydrobromide, guaifenesin syrup

  • NDC Code(s): 49873-302-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2023

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Purpose
    Dextromethorphan hydrobromide    Cough suppressant
    Guaifenesin    Expectorant

  • INDICATIONS & USAGE

    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.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    stonacoughsyrcartA.jpg Carton, panels 1, 2

  • PRINCIPAL DISPLAY PANEL

    stonacoughsyrcartB.jpg Carton, panels 3, 4

  • INGREDIENTS AND APPEARANCE
    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)
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