Label: GUAIFENESIN tablet

  • NDC Code(s): 73581-400-02, 73581-400-07
  • Packager: YYBA CORP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 24, 2026

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  • Active Ingredient (in each extended-release tablet)

    Guaifenesin 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

  • WARNING

    .

  • 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 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 and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.

    • children under 12 years: do not use.

  • Other information

    • tamper evident: Do not use if seal on bottle printed "SEALED for YOUR PROTECTION" is broken or missing.

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

  • Inactive Ingredients

    Carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone.

  • Questions?

    call 1-866-933-6337

    You may also report side effects to this phone number.

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code G233
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-400-021 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2026
    2NDC:73581-400-0770 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20921503/10/2026
    Labeler - YYBA CORP (006339772)
    Registrant - YYBA CORP (006339772)
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