Label: GILTUSS EX EXPECTORANT- guaifenesin solution

  • NDC Code(s): 65852-008-04
  • Packager: Dextrum Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 22, 2025

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  • Active Ingredients

    Active Ingredients

    Guafenesin, 400 mg Active ingredients

  • Uses

    Purpose

    Expectorant

    Uses

    • helps loosen phlegm ( mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
      uses

  • Warnings

    Warnings

    • Ask a doctor before use if you have , cough that occurs with too much phlegm ( mucus) , persistent or chronic cough such occurs with smoking, asthma, or chronic bronchitis or emphysema
      warnings
  • Stop Use

    Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistant cough may be a sign of a serious condition Stop use

  • If pregnant or breast -feeding

    If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately If pregnant

  • Directions

    Directions

    Do not take more than 6 doses in any 24 hours period

    Use enclosed dosing cup Directions

    Keep dosing cup for use this product

    ml= mililiters

    Adults and children 12 years & over 10 ml every 4 hours

    children 6 to under 12 years of age 5 ml every 4 hours

    children 4 to under 6 years of age 2.5 ml every 4 hours

    children under 4 years of age Consult a doctor

  • Other information

    Other information

    Store at room temperature 15-30 °C (59° -86 ° F)
    Close cap tightly
    SAVE CARTON FOR COMPLETE DRUG FACTS Other information

  • Inactive Ingredients

    Inactive Ingredients

    Citric acid, glycerin, methylparaben,natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, Inactive ingredients sucralose

  • Questions and comments

    Questions and comments?

    Call 1-787-848-9114, Monday-Friday 9AM-5PM EST

    call your doctor for medical advice in the event of side effects Questions

  • Indication and user section

    Indication and usage

    Do not take more than 6 doses in any 24- hours period.

    Keep sosage cup for use with this product

    Adults and children 12 years and over 10 ml every 4 hours

    Children 6 to under 12 years of age 5ml every 4 hours

    Children 4 to under 6 years of age 2.5ml ever 4 hours

    Children under 4 years of age Consult a doctor

    indication an user

  • Keep out of reach of children

    Keep out of reach of children.

    In case of accidental overdose, get medical or professional help or contact a Poison Control center immediately

    Keep out

  • PRINCIPAL DISPLAY PANEL

    Principal panelMaximun strength Giltuss EX Expectorant

    Guafenesin 400 mg

    Alcohol free, sugar free, Dye free, Non-Drowsy

    Chest congestion, Phlegm & Mucus

    Tutti Frutti Flavor

    4 floz 118 ml

  • INGREDIENTS AND APPEARANCE
    GILTUSS EX EXPECTORANT 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65852-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTUTTI FRUTTIImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65852-008-041 in 1 CARTON06/22/2020
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/22/2020
    Labeler - Dextrum Laboratories Inc. (007392322)
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