Label: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, extended release

  • NDC Code(s): 41415-994-18, 41415-994-36
  • Packager: PUBLIX SUPER MARKETS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 8, 2022

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

View All Sections
  • 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 68-77°F (20-25°C)
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    PUBLIX SUPER MARKETS, INC.,
    3300 PUBLIX CORPORATE PARKWAY
    LAKELAND, FL 33811

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

    NDC 41415-994-36

    12-HOUR

    mucusD

    GUAIFENESIN 600 mg &
    PSEUDOEPHEDRINE HCl 60 mg
    EXTENDED-RELEASE TABLETS

    EXPECTORANT & NASAL
    DECONGESTANT

    12 Hour

    • Clears Nasal/Sinus Congestion
    • Thins and Loosens Mucus
    • Immediate and Extended Release

    36
    EXTENDED-RELEASE
    TABLETS

    †Compare to the active
    ingredients of Mucinex® D

    PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    guaifenesin and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-994
    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:41415-994-181 in 1 CARTON04/07/2022
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41415-994-362 in 1 CARTON04/07/2022
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21254204/07/2022
    Labeler - PUBLIX SUPER MARKETS, INC (006922009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(41415-994)
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!