Label: GUAIFENESIN 200MG- guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 22, 2025

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  • Active ingredient (in each tablet)

    Guaifenesin 200 mg

  • Purpose

    Expectorant

  • Uses

    • Temporary symptomatic relief from congested chests and cough.
  • Warnings

    A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

    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)

    When using this product

    • Do not exceed recommended dosage.
    • Do not consume alcohol, benzodiazepines or opioids.

    Stop use and ask a doctor ifcough lasts for more than 7 days please consult your physicain or healthcare provider.

    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 (1-800-222-1222) right away.

  • Directions

    • Adults and children 12 years of age and over:take 1 tablet a day.
    • Children under 12 years:Do not use.
    • Do not exceed 4 doses in 24 hours.
  • Other Information

    • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
    • Keep in a dry place and do not expose to heat.
    • Read all product information before use. 
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive Ingredients

    Croscarmellose Sodium, Maltodextrin, Polyvinyl Pyrrolidone (PVPK30), Colloidal Silicon Dioxide, Microcrystalline Cellulose (PH-102), Stearic Acid Powder

  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 200MG 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-148
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-148-03300 in 1 BOTTLE; Type 0: Not a Combination Product08/22/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/22/2025
    Labeler - HEALTHLIFE OF USA LLC (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Ltd863182240manufacture(69517-148)
    Establishment
    NameAddressID/FEIBusiness Operations
    HHH PHARMA USA LLC062788820pack(69517-148)
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