Label: GUAIFENESIN DM- dextromethorphan hydrobromide,guaifenesin liquid

  • NDC Code(s): 71800-057-05
  • Packager: Innovida Pharmaeutique Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2025

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

  • Active Ingredient (in each 5mL tsp)

    Dextromethorphan HBr. USP 10 mg
    Guaifenesin USP 100 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 persistent 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)

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

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

     Adults and Children 12 years of age and over 10mL (2 teaspoonfuls every 4 hours or as directed by doctor)
     Children under 12 years of age Do not use

  • Other Information

    • store at room temperature
    • 15° to 30°C (59° to 86°F) TAMPER-EVIDENT;
    • do not use if seal under cap is torn broken or missing.
  • Inactive Ingredients

    CITRIC ACID, FD&C RED NO. 40, GLYCERIN, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, Strawberry Flavor, SUCRALOSE

  • Questions or Comments? 1-888-462-4166

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN DM 
    dextromethorphan hydrobromide,guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71800-057
    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
    CITRIC ACID (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71800-057-05119 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/20/2025
    Labeler - Innovida Pharmaeutique Corporation (080892908)