Label: TUSSIN SUGAR FREE COUGH- dextromethorphan hydrobromide, 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 November 14, 2009

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

  • Active Ingredients

    Dextromethorphan HBr,USP 10 mg Guaifenesin, USP 100 mg

  • Purpose

    Dextromethorphan HBr...................Cough suppressant Guaifenesin, USP..............................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 make coughs more productive


  • 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


  • When using this product

    • do not use more than directed

  • 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 this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • do not exceed 6 doses in a 24-hour period • this adult product is not intended for use in children under 12 years of age

                                                                    adults and children 12 years and over     2 teaspoonfuls (tsps) every 4 hours children under 12 years                              do not use AgeDose


  • Other Information

    sugar-free dosage cup provided

    • store at controlled room temperature

    alcohol-free




  • Inactive Ingredients

    acesulfame potassium, citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate


  • TUSSIN SUGAR FREE COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    TUSSIN SUGAR FREE COUGH  
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5180(NDC:0904-5180)
    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
    acesulfame potassium (UNII: 23OV73Q5G9)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    polyethylene glycol (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    propylene glycol (UNII: 6DC9Q167V3)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sodium benzoate (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-5180-110 mL in 1 CUP
    2NDC:17856-5180-25 mL in 1 CUP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/07/2009
    Labeler - Atlantic Biologicals Corps (047437707)
    Registrant - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL, REPACK