Label: CURAHIST DM- dextromethorphan hbr, pyrilamine maleate liquid

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

Drug Label Information

Updated April 4, 2024

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

  • DOSAGE & ADMINISTRATION

    Directions: Do not exceed the recommended dosage.

    Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not

    To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor

    Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not

    to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor

    Children under 6 years of age - consult a doctor

  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

    ■ a persistent cough may be a sign of a serious condition.

    If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

    Do not use this product

    ■ 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 MADI, ask a doctor or pharmacist before taking 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

    Ask a doctor before use if you have

    ■ a breathing problem such as emphysema or chronic bronchitis ■glaucoma ■difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you are taking sedatives or tranquilizers.

    When using this product

    ■ excitability may occur, especially in children ■may cause marked drowsiness ■ sedatives and tranquilizers may increase drowsiness effect ■avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding, ask a health professional before use.

  • INACTIVE INGREDIENT

    Inactive ingredients: Citric acid, flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

  • INDICATIONS & USAGE

    Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

    ■ runny nose ■sneezing ■itching of the nose or throat

    ■ itchy, watery eyes ■cough due to minor throat and bronchial irritation associated with a cold ■alleviates cough to help you sleep ■nonnarcotic cough suppressant for the relief of cough

  • KEEP OUT OF REACH OF CHILDREN

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

  • PURPOSE

    Antitussive/Antihistamine

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 ml teaspoonful)

    Dextromethorphan HBr 7.5mg

    Pyrilamine Maleate 7.5mg

  • PRINCIPAL DISPLAY PANEL

    CuraHIST DM Label

  • INGREDIENTS AND APPEARANCE
    CURAHIST DM 
    dextromethorphan hbr, pyrilamine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83335-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE (Apple Pie) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83335-105-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/15/2024
    Labeler - Wittman Pharma, Inc. (830980947)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wittman Pharma, Inc.830980947analysis(83335-105) , label(83335-105) , manufacture(83335-105)