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

Drug Label Information

Updated November 18, 2024

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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 DrugM01205/01/2023
    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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