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

  • NDC Code(s): 54859-603-02
  • Packager: Llorens Pharmaceutical 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 December 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients in each 1 mL (dropperful)                    Purpose

    Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant

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

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



  • PURPOSE

    Uses
    • Temporary relief of cough due to minor throat and
      bronchial irritation.
    • Temporarily relieves nasal congestion due to
      the common cold and thin bronchial secretions to make coughs
      more productive.
    • helps loosen phlegm (mucus) and thin bronchial
      secretions to make cough more productive.

  • WARNINGS


    Warnings

    Do not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, 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.
  • 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
  • DOSAGE & ADMINISTRATION


    Directions Do not exceed more than 4 doses in any 24-hour periodor 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

  • PRINCIPAL DISPLAY PANEL

    tusnelDMPed

  • INGREDIENTS AND APPEARANCE
    TUSNEL DM  PEDIATRIC
    dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-603
    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
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE2.5 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 (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:54859-603-0260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1993
    Labeler - Llorens Pharmaceutical International Division (037342305)
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