Label: TUSNEL PEDIATRIC- guiafenesin, pseudoephedrine hcl solution/ drops

  • 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 January 30, 2013

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!