Label: MEDIQUE MEDI-MUCUS- dextromethorphan hbr, guaifenesin tablet

  • NDC Code(s): 47682-432-46, 47682-432-50
  • Packager: Unifirst First Aid Corporation
  • 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 March 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • PURPOSE

    Purpose

    Cough suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

    Temporarily relieves:

    • cough due to minor throat irritations as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get sleep
  • WARNINGS

    Warnings

  • DO NOT USE

    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 DOCTOR

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with excessive phlegm (mucus)
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
  • WHEN USING

    When using this product

    • do not use more than directed
  • STOP USE

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children (12 years of age and older)

    Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

    Children under 12 years of age

    Do not use.

  • OTHER SAFETY INFORMATION

    Other information

    • store between 68-77ºF (20-25ºC)
    • keep in a dry place and do not expose to heat
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

  • QUESTIONS

    Questions or comments?

    Call 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique®

    Medi-Mucus

    Cough Suppressant • Dextromethorphan HBr 20 mg

    Expectorant • Guaifenesin 400 mg

    Controls Coughs Thins & Loosens Mucus

    Pull to Open

    Tamper Evident Unit Dose Packets

    Collect MediBuckSee inside flap for more details

    50 Tablets (50 x 1)

    Medique MediMucus

  • INGREDIENTS AND APPEARANCE
    MEDIQUE MEDI-MUCUS 
    dextromethorphan hbr, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-432
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code AH;432
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-432-5050 in 1 BOX05/01/2023
    1NDC:47682-432-461 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-432-461 in 1 PACKET; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2023
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(47682-432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(47682-432)
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