Label: DEFENSOL-ITO- dextromethorphan, guiafenesin, phenylephrine solution

  • Category: HUMAN OTC DRUG LABEL

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 August 12, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient (in each 1 mL, dropperful)                                      Purpose

    Dextromethorphan 4 mg............................................................................Cough Suppressant

    Guiafenesin 50 mg............................................................................Expectorant

    Phenylephrine HCl 2.5mg...................................................................Nasal Decongestant

  • PURPOSE

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses temporarily relives these symptoms occuring with cold:

    • nasal congestion
    • cough due to minor throat and bronchial irriatation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
  • 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.

    Ask a doctor before use if your child has

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

    When using this product, do not use more than directed

  • DO NOT USE

    Stop use and ask doctor if

    • your child gets nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days, comes back, or is accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could b signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    Keep ot of reach of children. In case of accidental overdose, get medical help or contact  a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than  doses in any 24-hour period
    • repeat every 4 hours
    • choose dosage by weight (if weight is not known, choose by age)
    • measure with the dosing device provided. Do not use with any other device.

    Age                              Weight                 Dose

    2 to under 6 years        24-47 Lbs           1 mL

    under 2 years               under 24 Lbs       ask  as doctor

  • OTHER SAFETY INFORMATION

    Drug Facts (continued)

    Other information

    • store at 20-20 C (68-77 F)
    • alcohol-free
    • oral dosingdevice enclosed

    Tamper-Evident: Do not use this product if seal on bottle is torn, broken or missing

  • QUESTIONS

    Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

  • INACTIVE INGREDIENT

    Inactive ingradients

    citric acid, corn syrup, FD&C yellow #6, flavor, glycerin, guar gum,menthol, methylparaben, propylene glycol, propylparaben, sodium saccharin, sucralose, water

  • PRINCIPAL DISPLAY PANEL

    Defensol-ito Label

  • INGREDIENTS AND APPEARANCE
    DEFENSOL-ITO 
    dextromethorphan, guiafenesin, phenylephrine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE4 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAR GUM (UNII: E89I1637KE)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-333-151 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2014
    Labeler - Menper Distributors, Inc (101947166)