Label: GUAIFENESIN liquid

  • NDC Code(s): 81033-102-16
  • Packager: KESIN PHARMA CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2025

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  • Drug Facts

    Active ingredient (in each 5 mL teaspoonful)

    Guaifenesin, USP 100 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
  • Warnings

    Do not use

    • if you ever had an allergic reaction to any of the ingredients in this product

    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, emphysema

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

    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.

  • Directions

    • take every 4 hours, as needed, or directed by a doctor
    • do not take more than 6 doses in 24 hours
    • do not exceed recommended dose

    AgeDose
    adults and children 12 years and over2 to 4 tespoonfuls every 4 hours
    children 6 years to under 12 years1 to 2 teaspoonfuls every 4 hours
    children 2 years to under 6 years1/2 to 1 teaspoonful every 4 hours
    under 2 yearsask a doctor

  • Other information

    • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
    • do not refrigerate
    • Do not use this product of printed inner seal is broken or missing
  • Inactive ingredients

    citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

  • Questions or comments?

    1-833-537-4679

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by the owner of registered trademark of Robitussin ®.

    Distributed by:

    Kesin Pharma

    Oldsmar, FL 34677

    Revision 03/2025

    Kesin Pharma Logo

  • PRINCIPAL DISPLAY PANEL

    NDC 81033-102-16

    Guaifenesin Oral Solution, USP

    100 mg/5 mL

    Expectorant

    Grape Flavor

    16 fl oz (473 mL)

    Guaifenesin 16 oz Bottle Label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-102
    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
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81033-102-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2025
    Labeler - KESIN PHARMA CORPORATION (117447816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kesin Pharma117447816pack(81033-102) , label(81033-102)
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