Label: COUGH SUPPRESSANT AND EXPECTORANT DM- tussin dm liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 2, 2016

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  • Active ingredients

    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 cold. It helps helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • Warnings

    Do not use 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.

  • Ask a doctor before use if

    • 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 if

    cough lasts more than 7 days, comes back, or accompanied by fever, rash, or persistant headache.

    These could be signs of a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Do not take more than 6 doses in a 24-hour period
    • Repeat dose every 4 hours while symptoms last

              AGE                                     DOSE

    adults and children

    12 years of age and over               10 mL    

    children 6 years to

    under 12 years of age                    5 mL

    children 2 years to

    under 6 years of age                      2.5 mL

    children under

    under 2 years of age                      ask a doctor

  • Other information

    • Store at 15-30°C (59-86°F)
    • Protect from freezing
    • Alcohol free
    • Protect from light
    • Each teaspoon 5mL contains: Sodium 3 mg
  • Inactive ingredients

    citric acid, dextrose**, flavor, FD&C red #40, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium,
    sodium benzoate

    ** contains one or more of these ingredients

  • Principal Display Panel

    Compare to the Active Ingredients in Robitussin DM

    Dextromethorphan HBr, 10 mg - guaifenesin, 100 mg

    cough suppressant, expectorant

    Non-Drowsy

    Alcohol Free

    Relieves- coughs, chest congestion and mucus

    2 FL Oz (60 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    COUGH SUPPRESSANT AND EXPECTORANT DM 
    tussin dm liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-044
    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 MONOHYDRATE (UNII: 2968PHW8QP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-044-011 in 1 CARTON06/29/2016
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/29/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINE PHARMA LLC019950491manufacture(70005-044)
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