TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MARC GLASSMAN, INC.]

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TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MARC GLASSMAN, INC.]
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NDC 68998-385-08
Set ID 97c8c15d-a64d-488b-885e-a6087db5b890
Category HUMAN OTC DRUG LABEL
Packager Marc Glassman, 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 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 (1-800-222-1222) right away.

  • Directions

    • shake well before using
    • 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
    • adults and children 12 years and over: 10 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

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

  • Principal Display Panel

    *Compare to active ingredients in Robitussin® Peak Cold Cough & Chest Congestion DM

    Adult

    Tussin DM

    Cough + Chest Congestion

    Dextromethorphan HBr

    (Cough suppressant)

    Guaifenesin

    (Expectorant)

    For relief of:

    • Cough
    • Mucus
    • For ages 12 and over
    • Alcohol Free
    • Non-drowsy

    FL OZ (mL)

    Dosing Cup Included

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Cough and Chest Congestion DM.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

    Distributed by:

    Marc Glassman, Inc.

    West 130th Street

    Cleveland, OH 44130

  • Package Label

    Dextromethorphan HBr 20 mg Guaifenesin 200 mg

    Marc's Adult Tussin DM

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM  COUGH AND CHEST CONGESTION
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-385
    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)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-385-081 in 1 BOX11/30/201412/30/2021
    1237 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 FINALpart34111/30/201412/30/2021
    Labeler - Marc Glassman, Inc. (094487477)
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