Label: GUAIFENESIN solution

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

Drug Label Information

Updated January 9, 2024

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  • PURPOSE

    Expectorant
    SUGAR FREE / ALCOHOL FREE

  • DESCRIPTION

    Each 5 mL (1 teaspoonful) contains:
    Guaifenesin 100 mg

  • Inactive Ingredients

    Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

    Sodium Content: 4 mg/5 mL

  • USES

    Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

  • WARNINGS

    Ask a doctor before use if you have

    •
    cough that occurs with too much phlegm (mucus)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    •
    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    •
    you are hypersensitive to any of the ingredients.

    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.

  • Professional Note

    Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

  • DIRECTIONS

    Follow dosage below or use as directed by a physician.

    •
    do not take more than 6 doses in any 24-hour period.
    agedose

    adults and children 12 years and over

    10 to 20 mL
    (2 to 4 teaspoonfuls)
    every 4 hours

    children 6 years to under 12 years

    5 to 10 mL
    (1 to 2 teaspoonfuls)
    every 4 hours

    children 2 to under 6 years of age

    2.5 to 5 mL
    (½ to 1 teaspoonful)
    every 4 hours

    children under 2 years of age

    consult a physician
  • STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

    Distributed by

    Cardinal Health

    Dublin, OH 43017

    L53963870124

    L54670551223

  • Principal Display Panel

    Guaifenesin Oral Solution, USP

    200 mg/10 mL

    5 cups

    Bag Label
  • Principal Display Panel

    Guaifenesin Oral Solution USP

    100 mg/5 mL

    5 Cups

    Bag Label
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5780(NDC:0121-1488)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-5780-55 in 1 BAG09/01/2002
    110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2002
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9450(NDC:0121-1744)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-9450-55 in 1 BAG09/01/2002
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2002
    Labeler - Cardinal Health 107, LLC (118546603)
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