Label: MUCUS RELIEF XPECT- guaifensin, dextromethorphan tablet

  • NDC Code(s): 63654-342-20, 63654-342-30
  • Packager: Selder, S.A. de C.V.
  • 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 October 14, 2022

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  • Active ingredients (in each tablet)

    Guaifenesin 400mg
    Dextromethorphan HBr 20mg

  • Purposes

    Expectorant
    Cough suppressant

  • Uses

    ■ helps loosen phlegm (mucus) ■ helps thin bronchial secretions to make coughs more productive ■ temporarily relieves cough due to minor sore throat and bronchial irritation associated with the 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 the MAOI drug.If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    ■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    Ask a doctor or pharmacist before use if you

    ■ are taking sedatives or tranquilizers.

    Stop use and ask a doctor if

    ■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

    These could be signs of a serious condition.

    Pregnancy/Breastfeeding

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

    Keep out of reach of children

    Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center 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 of age: do not use.

  • Other information

    ■ store at 25°C (77°F) excursions between 15°-30°C (59°-86°F) ■ Keep in a dry place and do not expose to heat ■ do not use if blister package is torn or damaged.

  • Inactive Ingredients

    alcohol, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate (derived from milk), magnesium stearate, polyethylene glycol, povidone, purified water, stearic acid

  • Questions or Comments?

    Call toll free 1-855-259-1590 Monday through Friday 9 AM - 5 PM EST.

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF XPECT 
    guaifensin, dextromethorphan tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-342
    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
    ALCOHOL (UNII: 3K9958V90M)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code XL3;XPECT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-342-202 in 1 CARTON05/19/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63654-342-303 in 1 CARTON05/19/2021
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01205/17/2021
    Labeler - Selder, S.A. de C.V. (824413629)
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