Label: MUCUS RELIEF PE SINUS CONGESTION- guaifenesin, phenylephrine hcl tablet, film coated

  • NDC Code(s): 70000-0141-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients (in each immediate-release tablet)

    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

  • Purpose

    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 the common cold, hay fever or other upper respiratory allergies
    • 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
    • difficulty in urination due to enlargement of the prostate gland
    • cough accompanied by too much phlegm (mucus)
    • 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 of 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

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

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • 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

    NDC 70000-0141-1

    LEADER™

    Mucus Relief PE
    Sinus Congestion

    Guaifenesin, 400 mg | Phenylephrine HCl, 10 mg
    Expectorant | Nasal Decongestant

    Relieves Nasal / Sinus Congestion
    Thins and Loosens Mucus
    Alleviates Chest Congestion

    Immediate-Release
    50 TABLETS

    Actual Size

    100% Money Back Guarantee

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    CardinalHealth™

    DISTRIBUTED BY
    CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com
    1-800-200-6313
    Essential to Care™ since 1979

    © 2021 Cardinal Health. All Rights Reserved. CARDINAL
    HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE,
    LEADER, and the Leader LOGO are trademarks or
    registered trademarks of Cardinal Health.

    ALL LEADER™ Brand Products Have A
    100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    50844    REV0118A54215

    Leader 44-542

    Leader 44-542

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF PE SINUS CONGESTION 
    guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 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
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 44;542
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0141-11 in 1 CARTON04/15/2006
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/15/2006
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70000-0141)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(70000-0141)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(70000-0141)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(70000-0141)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70000-0141)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!