Label: LIBI AIR VIRLAZA DEXTROMETHORPHAN COUGH SUPPRESSANT- dextromethorphan liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 30, 2024

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  • Drug Facts

  • Active ingredient (per mL)

    Dextromethorphan 10 mg

    Purpose

    Cough suppressant

  • Uses

    Temporarily calms Ê cough due to minor throat and bronchial irritation associated with the common cold.

  • Warnings

    Do not use

    • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    • 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.

    Stop use and ask a doctor if

    • cough lasts more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. Persistent cough may be a sign of a serious condition.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison ControlCenter right away.

  • Directions

    Adults and children 12 years and overDissolve 1mL in 50 mL of water and take by mouth every 4 hours. Do not take more than 6 mL in 24 hours.
    Children 6 to under 12 years of ageDissolve 0.5 mL in 25 mL of water and take by mouth every 4 hours. Do not take more than 3 mL in 24 hours.
    Children under 6 years of ageConsult a doctor

  • Other information:

    • Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from light.
  • Inactive ingredients

    basil extract, ethanol, eucalyptus extract, peppermint extract, pine extract, sage extract, sodium selenite, zinc gluconate

  • Questions or comments:

    1 (347) 767-6834

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    LIBI AIR VIRLAZA DEXTROMETHORPHAN COUGH SUPPRESSANT 
    dextromethorphan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84314-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SODIUM SELENITE (UNII: HIW548RQ3W)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84314-000-301 in 1 BOX01/07/2024
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/07/2024
    Labeler - Libi Pharm Ltd. (521953919)
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