Label: TUSNEL DIABETIC- dextromethorphan, guaifenesin liquid

  • NDC Code(s): 54859-505-04, 54859-505-16
  • Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
  • 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 10, 2022

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  • ACTIVE INGREDIENT

     Active Ingredients ( in each 5 mL tsp.)                                      Purpose

     Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant

     Guaifenesin USP ............. 100 mg ......................................... Expectorant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • WARNINGS

    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 if 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 giving this product.

  • DO NOT USE

    Ask a doctor before use if you have

    • a 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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could b a sign of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions

     Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

     Age Dose
     Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
     Under 2 years of age Do not use

  • INDICATIONS & USAGE

    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

  • INACTIVE INGREDIENT

    Inactive Ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate and sucralose.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

    Distributed By: Llorens International Division, Miami FL 33165

  • PRINCIPAL DISPLAY PANEL

    TusnelDiabeticLabel

  • INGREDIENTS AND APPEARANCE
    TUSNEL DIABETIC 
    dextromethorphan, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-505
    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
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-505-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2003
    2NDC:54859-505-16472 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2003
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
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