Label: GUAIFENESIN 100MG/5ML- guaifenesin solution

  • NDC Code(s): 84447-101-04, 84447-101-08, 84447-101-16
  • Packager: Belleview Biosciences
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 20, 2024

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  • Dosage & Admin

    Directions:

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

    AGEDOSE
    Adults & Children 12 years and over2-4 teaspoonfuls every 4 hours
    Children 6 years to under 12 years1-2 teaspoonfuls every 4 hours
    Children 2 to under 6 years

    1/2 - 1 teaspoonfuls every 4 hours
    Children Under 2 yearsAsk a Doctor

  • Warnings

    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.

    If pregnant of 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

  • INDICATIONS & USAGE

    Uses:

    ■ helps loosen phlegm (mucus) and thin bronchial secretions to make

    coughs more productive

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get

    medical help or contact a Poison Control Center right away.

  • PURPOSE

    Purpose: Expectorant

  • ACTIVE INGREDIENT

    Active Ingredient (in each 5 mL tsp)

    Guaifenesin 100 mg

  • PRINCIPAL DISPLAY PANEL

    84447-101 Bulk Label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 100MG/5ML 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84447-101
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84447-101-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2024
    2NDC:84447-101-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2024
    3NDC:84447-101-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2024
    Labeler - Belleview Biosciences (131968803)
    Registrant - Belleview Biosciences (131968803)
    Establishment
    NameAddressID/FEIBusiness Operations
    Belleview Biosciences131968803manufacture(84447-101) , label(84447-101) , analysis(84447-101)
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