GUAIFENESIN SOLUTION [CARDINAL HEALTH]

GUAIFENESIN SOLUTION [CARDINAL HEALTH]
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NDC 55154-5780-5, 55154-9450-5
Set ID 888b6a2e-6631-4585-a7fe-eb122eb51b23
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART341
  • 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

  • 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 finalpart34109/01/2002
    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 finalpart34109/01/2002
    Labeler - Cardinal Health (603638201)

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