Label: LEADER MUCUS RELIEF D- guaifenesin, pseudoephedrine hydrochloride tablet, multilayer, extended release

  • NDC Code(s): 70000-0719-1
  • Packager: Cardinal Health 110, LLC. dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 26, 2026

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  • Active ingredients (in each extended-release tablet)

    Guaifenesin 1200 mg

    Pseudoephedrine HCl 120 mg

  • Purposes

    Expectorant

    Nasal Decongestant

  • Uses

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

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland
    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    •
    cough accompanied by too much phlegm (mucus)

    When using this product

    •
    do not use more than directed

    Stop use and ask a doctor if

    •
    you get nervous, dizzy, or sleepless
    •
    symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

    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 (1-800-222-1222).

  • Directions

    •
    do not crush, chew, or break extended-release tablet
    •
    take with a full glass of water
    •
    this product can be administered without regard for timing of meals
    •
    adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
    •
    children under 12 years of age: do not use
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    LEADER™

    Maximum Strength

    Mucus Relief D

    Guaifenesin, 1200 mg

    Pseudoephedrine Hydrochloride, 120 mg

    Extended-Release Tablets

    Expectorant | Nasal Decongestant

    RELIEVES NASAL & CHEST CONGESTION

    12-Hour

    Clears Nasal & Sinus Congestion

    Thins & Loosens Mucus

    Immediate & Extended Release

    Actual Size

    COMPARE TO MUCINEX® D MAXIMUM STRENGTH active ingredients

    100% Money Back Guarantee

    24 EXTENDED-RELEASE TABLETS

    mucus-relief-d
  • INGREDIENTS AND APPEARANCE
    LEADER MUCUS RELIEF D 
    guaifenesin, pseudoephedrine hydrochloride tablet, multilayer, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0719
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code L12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0719-14 in 1 CARTON03/08/2025
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21440703/08/2025
    Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
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