Label: MUCUS RELIEF D SINUS CONGESTION- guaifenesin, pseudoephedrine hcl tablet, film coated

  • NDC Code(s): 63868-801-27
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2024

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  • Active ingredients (in each immediate-release tablet)

    Guaifenesin 400 mg
    Pseudoephedrine HCl 40 mg

  • Purpose

    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • promotes nasal and/or sinus drainage
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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.

    Ask a doctor before use if you have

    • cough accompanied by too much phlegm (mucus)
    • heart disease
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • high blood pressure
    • diabetes
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs or a serious condition.

    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

    • adults and children 12 years and over: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours.
    • children under 12 years: do not use
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • see end flap for expiration date and lot number
  • Inactive ingredients

    hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    QC®
    QUALITY
    CHOICE

    NDC 63868-801-27

    Mucus Relief D
    Sinus Congestion
    Guaifenesin 400 mg
    Pseudoephedrine HCl 40 mg

    Expectorant
    Nasal Decongestant

    Clears Nasal/Sinus Congestion
    Thins and Loosens Mucus

    Immediate Release

    Actual Size

    27 Tablets

    TAMPER EVIDENT: DO NOT USE IF
    PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    50844       ORG041954772

    SATISFACTION
    100 %
    QC
    GUARANTEED

    Distributed by C.D.M.A., Inc.©
    43157 W 9 Mile Rd
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 800-935-2362

    Quality Choice 44-547

    Quality Choice 44-547


  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF D SINUS CONGESTION 
    guaifenesin, pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code 44;547
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-801-273 in 1 CARTON04/23/2020
    19 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/23/2020
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(63868-801)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(63868-801)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(63868-801)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(63868-801)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(63868-801)
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