Label: CHILDRENS GILTUSS EX EXPECTORANT- guaifenesin solution

  • NDC Code(s): 58552-146-04
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)

    Guaifenesin, 200 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    Ask a doctor before use if your child has

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma or chronic bronchitis

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

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24-hour period
    • use enclosed dosing cup
    • keep dosage cup for use with this product
    • ml = milliliters
      children under 4 yearsConsult a doctor
      children 4 to under 6 years2.5 mL every 4 hours
      children 6 to under 12 years5 mL every 4 hours
      children 12 years and over10 mL every 4 hours
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • close cap tightly
    • SAVE CARTON FOR COMPLETE DRUG FACTS
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

  • SPL UNCLASSIFIED SECTION

    Tamper Evident: do not use if safety seal is broken or missing.

    MANUFACTURED FOR

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

    giltuss.com

  • PRINCIPAL DISPLAY PANEL

    Children 4-12

    Children's Giltuss® EX EXPECTORANT

    Alcohol Free, Sugar Free. Dye Free, Non Drowsy

    CHEST CONGESTION

    LIQUIFIES AND LOOSENS PHLEGM

    LIQUIFIES AND REMOVES MUCUS

    TUTTI FRUTTI FLAVOR

    4FL OZ (118 mL)

    58552-146 Expectorant Children

  • INGREDIENTS AND APPEARANCE
    CHILDRENS GILTUSS EX EXPECTORANT 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-146
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTUTTI FRUTTIImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-146-041 in 1 CARTON06/22/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/22/2020
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc007392322manufacture(58552-146)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!