Label: GUAIFENESIN D- guaifenesin and pseudoephedrine hydrochloride tablet, extended release

  • NDC Code(s): 70000-0580-1, 70000-0580-2
  • 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 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release tablet)Purposes
    Guaifenesin 600 mgExpectorant
    Pseudoephedrine HCl 60 mgNasal 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: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

  • Questions?

    call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984. You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

    LEADER™

    NDC 70000-0580-2

    Mucus
    Relief D
    Guaifenesin, 600 mg
    Pseudoephedrine Hydrochloride, 60 mg
    Extended-Release Tablets
    Expectorant | Nasal Decongestant

    12-Hour
    Clears Nasal/Sinus Congestion
    Thins and Loosens Mucus
    Immediate and Extended Release

    Actual Size

    36
    EXTENDED-RELEASE
    TABLETS

    COMPARE TO
    MUCINEX® D
    active ingredients†

    100% Money
    Back Guarantee

    PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN D 
    guaifenesin and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0580
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 058
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0580-11 in 1 CARTON05/06/2021
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0580-22 in 1 CARTON05/06/2021
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21254205/06/2021
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(70000-0580)
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