Label: CHILDRENS TUSSNEX MULTI-SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • 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 17, 2020

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  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Guaifenesin 100 mg

    Phenylephrine HCl 2.5 mg

  • Purpose

    Cough suppressant

    Expectorant

    Nasal decongestant

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose
  • Warnings

    Do not use in a 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 prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

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

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • your child gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever
    • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

    keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

  • Directions

    • do not take more than 6 doses in any 24 hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor

     AgeDose 
     children 6 years to under 12 years 10 mL every 4 hours
     children 4 years to under 6 years 5 mL every 4 hours
     children under 4 years do not use

  • Other information

    • each 5 mL contains: potassium 5 mg, sodium 5 mg
    • store between 15-30oC (59-86oF)
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    citric acid anhydrous, D and C red 33, dextrose, edetate disodium, FD and C blue 1, FD and C red 40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum

  • PDP

    compare to active ingredients in Mucinex children's Multi-symptom cold

    Children's Tussnex Multi-symptom cold

    Dextromethorphan HBr

    Cough suppressant

    Guaifenesin

    Expectorant

    Phenylephrine HCl

    Nasal decongestant

    Relieves nasal and chest chest congestion

    Thins and loosens mucus

    Soothes cough

    Alcohol freeNM

  • INGREDIENTS AND APPEARANCE
    CHILDRENS TUSSNEX MULTI-SYMPTOM COLD 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-615
    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) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-615-031 in 1 CARTON12/01/2012
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2012
    Labeler - Guardian Drug Company (119210276)