Label: CURATUSSIN DM- dextromethorphan hbr/guaifenesin liquid

  • NDC Code(s): 83335-102-04, 83335-102-08, 83335-102-16
  • Packager: Wittman Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Directions:
    ■ follow dosage below or use as directed by a physician
    ■ do not take more than 6 doses in any 24-hour period

    Dosage Table

  • WARNINGS

    Warnings: Do not use if you are now taking a prescription monoamine oxidase inhibitor (MADI)
    (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease),or for 2
    weeks after stopping the MADI drug.If you do not know if your
    prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product.t
    Ask a doctor before use if you have
    ■ cough that occurs with too much phlegm (mucus)
    ■ cough that lasts or is chronic, such as occurs with smoking, asthma,
    chronic bronchitis, or emphysema
    Stop use and ask doctor if


    ■cough lasts more than 7 days., comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    ■you are hypersensitive to any of the ingredients.

    If pregnant or breastfeeding, 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

  • INDICATIONS & USAGE

    Uses:

    ■ helps loosen phlegm(mucus) and thin bronchial secretions to make coughs more productive

    ■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get

    medical help or contact a Poison Control Center right away.

  • PURPOSE

    Purpose:

    Cough Suppressant and Expectorant

  • ACTIVE INGREDIENT

    Active Ingredient (in each 5 mL tsp)

    Dextromethorphan HBr 10mg

    Guaifenesin 100mg

  • PRINCIPAL DISPLAY PANEL

    CuraTUSSIN DM Label

  • INGREDIENTS AND APPEARANCE
    CURATUSSIN DM 
    dextromethorphan hbr/guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83335-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83335-102-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2024
    2NDC:83335-102-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2024
    3NDC:83335-102-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2024
    Labeler - Wittman Pharma, Inc. (830980947)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wittman Pharma, Inc.830980947analysis(83335-102) , manufacture(83335-102) , label(83335-102)