Label: DEXTROMETHORPHAN HBR, GUAIFENESIN capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 14, 2020

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 finalpart34102/18/2019
    Labeler - OPMX LLC (029918743)