Label: DEFENSOLITO CHILDREN SYRUP- guaifenesin, dextromethorphan hbr 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 February 18, 2022

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  • Active ingredients (in each 15mL tsp)

    Guaifenesin 100 mg………………………………Expectorant

    Dextromethorphan HBr 10 mg……………………Cough suppressant

  • Purpose 

    Expectorant

    Cough Suppressant

  • Uses

    Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

  • Warnings Do not exceed recommended dosage.

    A persistent cough may be a sign of a serious condition. If cough oersistent for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor. 

  • 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 child's prescription drug contains an MAOI ask a doctor or a pharmacist giving this product.
    • this product for persistent or chronic cough such as occur with asthma, or if cough is accompanied ny excessive phlegm (mucus) unless directed by a doctor.
  • Keep this and all drugs out of the reach of children

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

  • Directions

    do not exceed 6 doses in 24 hours

     Age Dose
     Children 6 to under 12 years of age  1 tablespoonful (15mL) every 4 hours
     Children 2 to under 6 years of age  1/2 tablespoonful (7.5 mL) every 4 hours 
     Children under 2 years of age  consult your doctor

  • Other information 

    store this product between 15° to 30° C (59° to 86°F)

  • Inactive ingredients 

    citric acid, D&C red #33, glycerin, methylparaben, natural raspberry flavor, propylene glycol, propylparaben, sucrose and water.

  • Question? 

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

  • PRINCIPAL DISPLAY PANEL

    Defensolito Children

  • INGREDIENTS AND APPEARANCE
    DEFENSOLITO CHILDREN SYRUP 
    guaifenesin, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    RASPBERRY (UNII: 4N14V5R27W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-008-041 in 1 CARTON02/21/2012
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
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