Label: GILTUSS CHILDRENS COUGH AND CHEST CONGESTION- dextromethorphan hydrobromide, guaifenesin solution

  • NDC Code(s): 58552-133-04
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)

    Dextromethorphan HBr, 10 mg

    Guaifenesin, 100 mg

  • PURPOSE

    Purposes

    Cough Suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves
    • cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
  • Warnings

    Do not useif your child is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if the child has

    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

    Stop use and ask a doctor or pharmacist if the child has

    • symptoms do not get better within 7 days or are accompanied by fever
    • cough comes back, or is accompanied by fever, rash, or persistent headache.

    These could be signs of a serious condition.

    When using this product

    • do not use more than directed.

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24 hour period
    • use enclosed dosing cup
    • keep dosing cup for use with this product
    • mL = milliliters
    children under 2 yearsConsult a doctor
    children 2 to under 6 years of age2.5 mL every 4 hours
    children 6 to under 12 years of age5 mL every 4 hours
    children 12 years and over10 mL every 4 hours

  • SPL UNCLASSIFIED SECTION

    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, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

  • 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

  • PRINCIPAL DISPLAY PANEL

    Children's

    GILTUSS®

    COUGH & CHEST CONGESTION

    ANTITUSSIVE AND EXPECTORANT

    Non-Drowsy. Alcohol Free

    • COUGH AND COLD
    • CHEST CONGESTION
    • LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

    RASPBERRY FLAVOR

    4FL OZ (118 mL)

    58552-133 Child CoughChestCongestion

  • INGREDIENTS AND APPEARANCE
    GILTUSS CHILDRENS COUGH AND CHEST CONGESTION 
    dextromethorphan hydrobromide, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-133-041 in 1 CARTON10/02/2018
    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 DrugM01210/02/2018
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(58552-133)
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