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

  • NDC Code(s): 70000-0721-1
  • 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 March 9, 2025

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  • Active ingredient (in each extended-release tablet)

    Guaifenesin 1200 mg

  • Purpose

    Expectorant

  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Do not use

    •
    for children under 12 years of age

    Ask a doctor before use if you have

    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    •
    cough accompanied by too much phlegm (mucus)

    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.

    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 of age and over: 1 extended-release tablet every 12 hours. Do not exceed 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, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    LEADER™

    Maximum Strength

    Mucus Relief

    Guaifenesin Extended-Release Tablets, 1200 mg

    Expectorant

    12-Hour

    Relieves Chest Congestion

    Thins and Loosens Mucus

    Immediate and Extended Release

    Actual Size

    COMPARE TO MAXIMUM STRENGTH MUCINEX® active ingredient

    14 EXTENDED-RELEASE TABLETS

    100% Money Back Guarantee

    mucus-relief-carton
  • INGREDIENTS AND APPEARANCE
    LEADER MUCUS RELIEF 
    guaifenesin tablet, multilayer, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0721
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code L4S1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0721-12 in 1 CARTON03/09/2025
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07891203/09/2025
    Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
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