TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]

TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]
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NDC 54859-544-04, 54859-544-16
Set ID 82f447f6-4f1b-4f56-9d7d-ea02adeea88c
Category HUMAN OTC DRUG LABEL
Packager Llorens Pharmaceutical International Division
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients(in each 5 ml tsp.)                                  Purpose

    Dextromethorphan HBr........5mg..................................................Cough Suppressant

    Guaifenesin........................50mg................................................Expectorant

    Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant



  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • 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 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.

  • DO NOT USE


    Ask a doctor before use if your child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a cough that occurs with too much phlegm (mucus)
    • a persistent or chronic cough such as occurs with asthma


    When using this product

    • do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not get better within 7 days or accompanied by fever
    • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed more than 4 doses in any 24-hour period
    or as directed by a doctor.

    AgeWeightDose
    Children 6 to under
    12 years of age
    45 lbs to under
    95 lbs
     Take 2 teaspoonfuls (10 mL)
     every 4 to 6 hours
    Children 2 to under
    6 years of age
    25 lbs to under
    45 lbs
     Take 1 teaspoonful (5mL)
     every 4 to 6 hours
    Children under 2 years of ageUnder 25 lbs ask a doctor

  • INDICATIONS & USAGE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.
  • INACTIVE INGREDIENT


    Inactive ingredients
    astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    tusnelpediatriclabel

  • INGREDIENTS AND APPEARANCE
    TUSNEL  PEDIATRIC
    dextromethorphan, guiafenesin, pseudoephedrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-544
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin50 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-544-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    2NDC:54859-544-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2006
    Labeler - Llorens Pharmaceutical International Division (037342305)