Label: TUSNEL-DM PEDIATRIC- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

  • NDC Code(s): 54859-606-01
  • Packager: LLORENS PHARMACEUTICALS 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 29, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients in each (1 mL)

    Dextromethorphan HBr 2.5 mg

    Guaifenesin 25 mg

    Phenylephrine HCl 1.25 mg

  • PURPOSE

    Purpose

    Cough suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    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 whos 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 your doctor or pharmacist before giving this product.

    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
    • a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

    When using this product

    • do not exceed the recommended dosage.
    Stope use and ask doctor if
    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not get better within 7 days or accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case 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 Weight Dose
     Children 2 to under 6 years of age 24-47 lbs Take 2 mL every 4-6 hours
     Children under 2 years of age Under 24 lbs Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    TUSNEL-DM PEDIATRIC 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN25 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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:54859-606-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2019
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
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