Label: DEFENSOL ADULT SYRUP- guaifenesin, dextromethorphan hbr liquid

  • NDC Code(s): 53145-039-04
  • Packager: Menper Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2025

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

  • Active ingredients (in each 10mL tsp)

    Dextromethorphan HBr 20 mg……………………Cough suppressant

    Guaifenesin 200 mg………………………………Expectorant

  • Purposes

    Cough Suppressant

    Expectorant

  • Uses

    Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin brochial secretions to make cougs  more productive. 

  • Warnings

    Do not exceed recommended dosage.

    A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

  • Do not use:

    • This product for persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
    • 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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • If you are pregnant or breast-feeding,

    ask a health professional before use.

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

  • Directions:Do not exceed 6 doses in 24 hours.

     age dose
     Adults and children12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
     Children under 12 years of age Do not use

  • Other information

    • Store this product between 15°-30°C (59°-86°F)
  • Inactive ingredients

    citric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben ,raspberry flavor, sucrose,water,

  • Question?

    call 1-800-560-5223 M-F 9 AM- 4PM Eastern

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DEFENSOL ADULT SYRUP 
    guaifenesin, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-039
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-039-041 in 1 CARTON02/21/2012
    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 DrugM01202/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNV, LLC118917568manufacture(53145-039)