Label: GILTUSS DM- dextromethorphan hbr syrup

  • NDC Code(s): 58552-150-04
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • Drug Facts

    Active ingredient (in each 10 mL) Purpose

    Dextromethorphan HBr. 30 mg .... Cough Suppresant

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    ■ temporarily relieves:

    • cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
  • WARNINGS

    Warnings

    Do not use

    • if 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.
    • When using this product do not use more than directed.

    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 if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as 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 exceed recommended dosage
    • do not take more than 4 doses in any 24-hour period
    • use enclosed dosing cup
    • ml= milliliter

    Adults and children over 12 years

    10 mL every 8 hours

    Children under 6 years to under 12 years

    5 mL every 8 hours

    Children 4 years to under 6 years

    2.5 mL* every 8 hours

    Children under 4 years

    Do not use

    *use appropriate measuring syringe or measuring cup

  • 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

    Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin.

  • 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.

    Label revised: 02/23

    MANUFACTURED FOR
    GIL PHARMACEUTICAL CORP.
    PONCE, PUERTO RICO 00717-1565

  • PRINCIPAL DISPLAY PANEL

    Giltuss DM High Blood Pressure - NDC 58552-150-04 - Bottle Label

    image description

    Giltuss DM High Blood Pressure - NDC 58552-150-04 - Carton Label

    image description

  • INGREDIENTS AND APPEARANCE
    GILTUSS DM 
    dextromethorphan hbr syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-150
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    RASPBERRY (UNII: 4N14V5R27W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorwhite (clear color) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-150-041 in 1 CARTON08/09/2023
    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 DrugM01206/27/2023
    Labeler - Gil Pharmaceutical Corp (176826592)
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