TUSNEL PEDIATRIC (GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]

TUSNEL PEDIATRIC (GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]
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NDC 54859-602-02
Set ID f9fe6883-6e10-4851-8acb-a6df6e862375
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 1 mL (dropperful)                    Purpose

    Guaifenesin........................25mg................................................Expectorant

    Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant



  • PURPOSE

    Uses
    • temporarily relieves these symptoms due to the common cold and thin bronchial secretions to make coughs more productive
  • WARNINGS


    Warnings

    Do not use in child who is 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 child's prescription drug contains an
    MAOI, ask a doctor or pharmacist before giving 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.

    Age
    WeightDose
    Children 2 to under
    6 years of age
    24 -47 lbs
     Take 2 mL (two dropperfuls)
     every 4 to 6 hours
    Children under 2 years of age
    Under 24 lbs
     ask a doctor

  • INDICATIONS & USAGE


    Other information
    • store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]
    • Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering
    • Oral dosing device enclosed
  • INACTIVE INGREDIENT


    Inactive ingredients
    citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.
  • QUESTIONS

    Questions or Comments? 1-866-595-5598
  • PRINCIPAL DISPLAY PANEL

    tusnelpediatricdropslabel
  • INGREDIENTS AND APPEARANCE
    TUSNEL PEDIATRIC 
    guiafenesin, pseudoephedrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-602
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin25 mg  in 1 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-602-0260 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2006
    Labeler - Llorens Pharmaceutical International Division (037342305)