TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]

TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]
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NDC 54859-505-04, 54859-505-16
Set ID 66b3c094-809e-4d2c-bc15-46563de685cb
Category HUMAN OTC DRUG LABEL
Packager LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Generic Name
Product Class
Product Number
Application Number PART341
  • 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)