TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [PUBLIX SUPER MARKETS INC]

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  • TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [PUBLIX SUPER MARKETS INC]

TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [PUBLIX SUPER MARKETS INC]
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NDC 56062-359-26, 56062-359-34
Set ID 5b0603e5-d08a-4911-859c-56f2bbafb7e6
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 200 mg

  • Purposes

    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 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

    •
    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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

  • Directions

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    keep dosing cup with product
    •
    mL = milliliter
    •
    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    10 mL every 4 hours

    children under 12 years

    do not use
  • Other information

    •
    each 10 mL contains: sodium 6 mg
    •
    store at 20-25°C (68-77°F).
     
    Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

  • Principal Display Panel

    ADULT tussin DM

    COUGH SUPPRESSANT (DEXTROMETHORPHAN HBr)

    EXPECTORANT (GUAIFENESIN)

    Relieves:

    Cough

    Mucus

    Compare to the active ingredients in Robitussin® Cough + Chest Congestion DM

    FOR AGES 12 & OVER NON-DROWSY

    4 FL OZ (118 mL)

    359-63-tussin-dm.jpg
  • INGREDIENTS AND APPEARANCE
    TUSSIN DM 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-359
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED (clear) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-359-261 in 1 CARTON02/10/2014
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:56062-359-341 in 1 CARTON02/10/2014
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/10/2014
    Labeler - Publix Super Markets Inc (006922009)
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