Label: CHILDRENS GILTUSS HONEY DM COUGH- dextromethorphan hbr solution

  • NDC Code(s): 58552-144-04
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)

    Dextromethorphan HBr, 15 mg

  • PURPOSE

  • 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
  • WARNINGS

    Warnings

    Do not use if 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 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 persistent or chronic cough such as occurs with asthma

    Stop use and ask a doctor if the child has a cough that lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs 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 4 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 6-8 hours
    children 6 to under 12 years5 mL every 6-8 hours
    children 12 years and over10 mL every 6-8 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 ingredients natural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, 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®

    Honey DM Cough

    Alcohol Free. Dye Free. Non Drowsy.

    PERSISTENT COUGH UP TO 8 HOURS

    Made with real honey

    HONEY LEMON FLAVOR.

    4FL OZ (118 mL)

    58552-144 Honey DM Child

  • INGREDIENTS AND APPEARANCE
    CHILDRENS GILTUSS HONEY DM COUGH 
    dextromethorphan hbr solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-144
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HONEY (UNII: Y9H1V576FH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Coloryellow (Light yellow) Score    
    ShapeSize
    FlavorHONEY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-144-041 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 finalpart34106/22/2020
    Labeler - Gil Pharmaceutical Corp (176826592)
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