TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [KAREWAY PRODUCT, INC.]

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TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [KAREWAY PRODUCT, INC.]
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NDC 67510-0527-4
Set ID e2314ad3-51d2-43aa-b7b0-23c0c7ae6e4d
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients

    (in each 5mL tsp)

    Dextromethorphan HBr, USP 10mg

    Guaifenesin, USP 100mg

  • Purpose

    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

    • a cough that occurs with too much phlegm (mucus)
    • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor ir

    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

    • do not take more than 6 doses in any 24-hour period

    Age
    		Dose
    adults and children 12 years and over
    		2 tsp every 4 hours
    children 6 years to under 12 years
    		1 tsp every 4 hours
    children 2 years to under 6 years
    		1/2 tsp every 4 hours
    children under 2 years
    		ask a doctor
  • Other information

    • store at 20-25°C (68-77°F)
    • alcohol-free
    • dosage cup provided
  • Inactive ingredients

    cherry flavor, citric acid, FD and C red no. 40, glycerin, sucrose, sucralose, menthol, propylene glycol, purified water, xanthan gum, polysorbate, sorbitol solution, sodium benzoate

  • Package label

    Tussin DMimage of carton label

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0527
    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) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHERRY (UNII: BUC5I9595W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE (UNII: C151H8M554)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0527-41 in 1 BOX
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/26/2011
    Labeler - Kareway Product, Inc. (121840057)
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