Label: TUSSIN DMMAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin 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 18, 2013

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  • Active ingredients (in each 5 mL tsp)

    Dextromethorphan HBr, USP 10mg

    Guaifenesin, USP 200mg

  • Purposes

    Cough suppressant

    Expectorant

    Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

    temporarily relieves:

    • cough due to minor bronchial irritation as may occur with a cold or inhaled irritants
    • the impulse to cough

  • INDICATIONS & USAGE


  • KEEP OUT OF REACH OF CHILDREN


  • 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 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 if

    cough 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 health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

  • Directions

    • shake well before using
    • do not take more than 6 doses in any 24-hour period
    • only use the measuring cup that is included with this product for accurate dosing


    Age
    		Dose
    adults and children 12 years and over
    		2 tsp (10ml) every 4 hours
    children under 12 years
    		do not use




  • Other information

    • each teaspoon contains: sodium 5 mg
    • store at 20-25oC (68-77oF)
    • do not refrigerate
    • alcohol-free
    • measuring cup provided
  • Inactive ingredients:

    artificial and natural flavors, carboxymethylcellulose sodium, citric acid, Dand C red no. 33, FD and c red no. 40, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, xanthan gum

  • Principal Display panel

    NDC 59779-967-04

    Compare to the active ingredients in Adult Robitussin Cough and Chest congestion

    Maximum Strength
    Tussin DM
    Adult Cough and chest congestion

    Cough Supressant (Dextromethorphan HBr)
    Expectorant (Guaifenesin)

    Relieves:
    Cough
    Chest congestion/mucus

    alcohol free
    Non-Drowsy

    For ages 12 and over
    8 fl oz (237 mL)

    1 imageimage 1
    2 imageimage 2

  • INGREDIENTS AND APPEARANCE
    TUSSIN DMMAXIMUM STRENGTH  
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-967
    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) GUAIFENESIN200 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-967-031 in 1 CARTON
    1118 mL in 1 BOTTLE
    2NDC:59779-967-041 in 1 CARTON
    2237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2009
    Labeler - CVS Pharmacy (062312574)
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