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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2024

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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 DrugM01212/01/2012
    Labeler - Guardian Drug Company (119210276)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(53041-615)
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