TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.]

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TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-1934-1, 54868-1934-2
Set ID 71e383f3-8c7e-4140-bdc9-114c31a8806f
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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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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