Label: GOOD SENSE TUSSIN DM COUGH AND CHEST CONGESTION- 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 July 17, 2013

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5 mL tsp)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

  • 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

    • 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.

  • 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
    agedose

    adults and children

    12 years and over

    2 teaspoons

    every 4 hours
    children under 12 yearsdo not use
  • Other information

    • Phenylketonurics: contains phenylalanine 15 mg per teaspoon
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    aspartame, benzoic acid, flavors, glycerin, hydroxyethyl cellulose, polyethylene glycol, purified water

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Non-Drowsy

    See New Dosing Directions

    Tussin DM

    Cough & Chest Congestion

    Sugar-Free

    Cough Suppressant (Dextromethorphan HBr)

    Expectorant (Guaifenesin)

    Relieves:
    Coughs

    Chest Congestion

    Mucus

    Specially Formulated for Diabetics

    Adult

    For Ages 12 & Over

    Alcohol & Sugar Free

    Compare to active ingredients of Robitussin® Cough & Chest Congestion Sugar-Free DM

    NDC 68258-8905-04

    NDC 68258-8905-04

  • INGREDIENTS AND APPEARANCE
    GOOD SENSE TUSSIN DM  COUGH AND CHEST CONGESTION
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68258-8905(NDC:0113-0578)
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68258-8905-4118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/20/1994
    Labeler - Dispensing Solutions, Inc. (066070785)
    Registrant - PSS World Medical, Inc. (101822682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785relabel(68258-8905) , repack(68258-8905)