Label: GILTUSS HONEY DM COUGH- dextromethorphan hbr solution

  • NDC Code(s): 58552-143-04
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 10 mL)

    Dextromethorphan HBr, 30 mg

  • PURPOSE

    Purposes

    Cough Suppresant

  • 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 useif you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor ifcough 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.

    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 4 doses in any 24-hour period
    • use enclosed dosing cup
    • keep dosage cup for use with this product
    • ml = milliliters
      adults and children 12 years and over10 mL every 6-8 hours
      children 6 to under 12 years of age5 mL every 6-8 hours
      children 4 to under 6 years of age2.5 mL every 6-8 hours
      children under 4 years of ageConsult a doctor
  • 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 ingredientsnatural 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

    MAXIMUM STRENGTH

    Giltuss®

    Honey DM Cough

    Made with real honey

    ALCOHOL FREE. DYE FREE. NON-DROWSY

    RELIEVES

    PERSISTENT COUGH UP TO 8 HOURS

    HONEY LEMON FLAVOR.

    4FL OZ (118 mL)

    58552-143 Honey DM

  • INGREDIENTS AND APPEARANCE
    GILTUSS HONEY DM COUGH 
    dextromethorphan hbr solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-143
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 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:58552-143-041 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(58552-143)
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