Label: PHARBINEX-DM- guaifenesin 400mg and dextromethorphan hbr 20mg tablet

  • NDC Code(s): 16103-381-04
  • Packager: Pharbest Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 24, 2025

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  • Drug Facts

  • Active ingredients (in each tablet)

    Guaifenesin 400mg

    Dextromethorphan HBr 20mg

  • Purpose

    Expectorant

    Cough suppressant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    • helps make cough more productive
    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
  • 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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

    Directions

    • take with a full glass of water
    • do not exceed 6 doses in 24 hours

    adults and children 12 years of age and over

    take 1 tablet every 4 hours as needed

    children 6 to under 12 years of age

    take ½ tablet every 4 hours as needed

    children under 6 years of age

    consult a doctor

  • Other information

    • store at room temperature (15°-30°C)
    • Tamper Evident: do not use if safety seal under cap is broken or missing
  • Inactive ingredients

    magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid.

  • Questions?

    Adverse drug event call (866) 562-2756 Mon-Fri 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    PHARBEST 

    NDC 16103-381-04

    Manufactured in the USA

    Immediate Release

    PHARBINEX-DM

    *Compare to the active ingredient in MUCINEX® DM Tablets

    Guaifenesin 400mg

    Dextromethorphan HBr 20mg

    Expectorant &

    Cough Suppressant

    30 TABLETS

    Pharbinex DM Tablet Product Label

  • INGREDIENTS AND APPEARANCE
    PHARBINEX-DM 
    guaifenesin 400mg and dextromethorphan hbr 20mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-381
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULE (CAPSULE SHAPED TABLET) Size18mm
    FlavorImprint Code PH073
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-381-041 in 1 CARTON04/02/2018
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/02/2018
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-381) , analysis(16103-381) , pack(16103-381) , label(16103-381)
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