Label: DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

  • NDC Code(s): 84415-011-01, 84415-014-01
  • Packager: Everpharm LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 16, 2025

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  • DRUG FACTS

    10 mg-100 mg/5 mL -

    Active ingredient per 5 mL(1 unit dose) 

    Dextromethorphan HBr. 10 mg

    Guaifenesin 100 mg

    20 mg-200 mg/10 mL -

    Active ingredient per 10 mL(1 unit dose)    

    Dextromethorphan HBr. 20 mg

    Guaifenesin 200 mg

  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

    •   temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    •   helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

  • 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

    •   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 a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

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

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    •   do not take more than 6 doses in any 24 hour period

    20 mg-200 mg/10 mL

    agedose
    Children under 12 years of age

    Do not use
    Adults and children over 12 years of age

    10 mL (1 unit dose) every 4 hours

    10 mg-100 mg/5 mL

    agedose
    Children under 6 years of ageDo not use
    Children 6 to under 12 years of age5 mL (1 unit dose) every 4 hours
    Adults and children over 12 years of age10 mL (2 unit dose) every 4 hours

  • OTHER SAFETY INFORMATION

    Other Information
    •   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

    •   do not use if lid is torn or broken

  • INACTIVE INGREDIENT

    Inactive Ingredientscitric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

  • QUESTIONS

    Questions or comments? Call (866) 838-3774

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    EverPharm

    NDC 84415-014-01

    Dextromethorphan HBr. 

    and Guaifenesin 

    Oral Solution

    Cough Suppressant/

    Expectorant

    10 mg-100 mg/5 mL

    • Alcohol Free

    • Sugar Free

    • Cherry Flavor

    For Institutional Use Only

    100 x 5 mL Unit-Dose Cups

    10label

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    EverPharm

    NDC 84415-011-01

    Dextromethorphan HBr.

    and Guaifenesin

    Oral Solution

    Cough Suppressant/

    Expectorant

    20 mg-200 mg/10 mL

    • Alcohol Free

    • Sugar Free

    • Cherry Flavor

    For Institutional Use Only

    100 x 10 mL Unit-Dose Cups

    5label

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
    dextromethorphan hbr. and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84415-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84415-014-01100 in 1 BOX, UNIT-DOSE01/16/2025
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/16/2025
    DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
    dextromethorphan hbr. and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84415-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84415-011-01100 in 1 BOX, UNIT-DOSE06/12/2023
    110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM012.8506/12/2023
    Labeler - Everpharm LLC (119288836)
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