Label: DEXTROMETHORPHAN HBR, GUAIFENESIN capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Dextromethorphan HBr 20mg

    Guaifenesin 400mg

  • PURPOSE

    Cough suppressant

    Expectorant

  • INACTIVE INGREDIENT

    FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

  • DOSAGE & ADMINISTRATION

    Do not take more than directed – See overdose warning
    Do not use for more than 7 days
    Do not take more than 6 doses in 24 hours

    Adults and children 12 years of age and over: take 1 softgel every 4 hours with a full glass of water while symptoms persist

    Children under 12 years of age: do not use

  • INDICATIONS & USAGE

    Helps loosen phlegm (mucus)
    Helps thin bronchial secretions to make coughs more productive

  • WARNINGS

    Do not 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.

    Ask a doctor before use if you have:

    • Cough that occurs with too much phlegm (mucus)
    • Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if:

    Cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition

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

    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • OVERDOSAGE

    OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • OTHER SAFETY INFORMATION

    store at room temperature between 20-25°C (68-77ºF)

    avoid excessive heat and humidity

  • PRINCIPAL DISPLAY PANEL

    PENTREXCILINA

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR, GUAIFENESIN 
    dextromethorphan hbr, guaifenesin capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-781
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Coloryellow (LIGHT YELLOW) Scoreno score
    ShapeOVAL (Oblong) Size20mm
    FlavorImprint Code 781
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-781-0220 in 1 BLISTER PACK; Type 0: Not a Combination Product02/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/18/2019
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(69729-781)