Label: TUSSIN DM- guaifenesin and dextromethorphan hydrobromide 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 June 17, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: Guaifenesin 100 mg (in each 5 mL)

    Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL)

  • PURPOSE

    Purpose of Guaifenesin: Expectorant

    Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation
    • 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 you have

    • persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
    • cough accompanied by excessive phlegm (mucus)
  • Stop use and ask a doctor if

    • cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition
    • hypersensitive to any ingredients
  • If pregnant or breast-feeding

    • ask a health professional before use.
     
  • 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.

  • Directions

    do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

    Adults and children 12 years and over
    		2 teaspoonfuls (10 mL)
    every 4 hours
    Children under 12 yearsDO NOT USE

  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.

  • Other information

    store at room temperature 20°-25°C (68°-77°F)

  • QUESTIONS

    Questions: 888-974-5279


    Manufactured by

    Silarx Pharmaceutical Inc,

    19 West Street , Spring Valley

    NY - 10977- USA.


    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, OK      74146

  • PRINCIPAL DISPLAY PANEL


    Tussin-DM (OTC)

    NDC 54868-1934-2

    237 mL

    image of package label


  • INGREDIENTS AND APPEARANCE
    TUSSIN DM 
    guaifenesin and dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1934(NDC:54838-209)
    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
    citric acid (UNII: 2968PHW8QP)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    menthol (UNII: L7T10EIP3A)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sucrose (UNII: C151H8M554)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (STRAWBERRY FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-1934-1118 mL in 1 BOTTLE, PLASTIC
    2NDC:54868-1934-2237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/03/2009
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel, repack
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