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

  • NDC Code(s): 47682-345-46, 47682-345-50
  • 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 February 2, 2023

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

  • Drug Facts

  • Active ingredients (in each tablet)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • Purpose

    Cough suppressant

    Expectorant

  • 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

    ■ 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. complete

    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 a doctor or pharmacist before use if you are

    ■ taking sedatives or tranquilizers

    When using this product

    ■ do not use more than directed

    Stop use and ask a doctor if

    ■ cough lasts for more than 7 days, comes back or occurs with 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.

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

  • Directions

    Adults and children:

    (12 years 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

    Do not use.

  • Other information

    ■ store at room temperature 68º-77ºF (20º-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 ingredients

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

  • Questions or comments?

    Call 1-800-634-7680

  • Medique Medi-Mucus Label

    Collect MediBucks

    See inside flap for more details

    Medique®

    Medi-Mucus

    Controls Coughs

    Thins & Loosens Mucus

    Pull To Open

    ✓ Cough Supressant • Dextromethorphan HBr 20mg

    ✓ Expectorant • Guaifenesin 400mg

    50 Tablets

    (50 x 1)

    Tamper Evident Unit Dose Packets

    2 Medi-Mucus

  • INGREDIENTS AND APPEARANCE
    MEDIQE MEDI-MUCUS 
    dextromethorphan hbr, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-345
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code AZ;345
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-345-5050 in 1 BOX06/03/201907/01/2024
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-345-461 in 1 PACKET; Type 0: Not a Combination Product06/03/201907/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/03/201907/01/2024
    Labeler - Unifirst First Aid Corporation (832947092)