Label: 365 WHOLE FOODS MARKET GUAIFENESIN- guaifenesin tablet, extended release

  • NDC Code(s): 42681-0057-1
  • Packager: Whole Foods Market, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 20, 2026

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  • Active ingredient

    (in each extended-release tablet)
     Guaifenesin USP 600 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 the timing of meals
    • adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients


    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

  • Questions?

    1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


    DISTRIBUTED BY:
    WHOLE FOODS MARKET
    550 BOWIE STREET, AUSTIN, TX 78703
    ©2025 WHOLE FOODS MARKET IP, INC.
    www.wholefoodsmarket.com

    PRODUCT OF INDIA

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablets Container Label)

    365
    WHOLE FOODS
    MARKET

    NDC 42681-0057-1

    Expectorant

    Mucus Relief

    Guaifenesin
    Extended-Release Tablets 600mg
    Guaifenesin 600mg- Expectorant
    Relieves Chest Congestion
    Thins & Loosens Mucus

    12                        20
    Hour               Extended-Release 
                            TABLETS

    FIG


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablets Container Carton)

    365
    WHOLE FOODS
    MARKET

    NDC 42681-0057-1

    Expectorant

    Mucus Relief

    Guaifenesin
    Extended-Release Tablets 600mg
    Guaifenesin 600mg - Expectorant

    Compare to the Active Ingredient in Mucinex®**

     

    Relieves Chest Congestion
    Thins & Loosens Mucus

    12 Hour

    for Day or Night

     

    ACTUAL SIZE               20

                              Extended-Release 
                                      TABLETS

    FIG


  • INGREDIENTS AND APPEARANCE
    365 WHOLE FOODS MARKET GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-0057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POVIDONE K25 (UNII: K0KQV10C35)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code L;68
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-0057-11 in 1 CARTON01/23/2026
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21045301/23/2026
    Labeler - Whole Foods Market, Inc. (196175616)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(42681-0057) , MANUFACTURE(42681-0057)
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