Label: BRONKIDS- chlorpheniramine/dextromethorphan/phenylephrine 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 4, 2010

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  • ACTIVE INGREDIENT

    Active ingredients                                                       Purpose
    (in each teaspoonful (5 mL)
    Chlorpheniramine
    Maleate 4 mg ...................................................... Antihistamine
    Dextromethorphan
    HBr 15 mg ............................................................... Antitussive
    Phenylephrine
    HCl 10 mg ................................................. Nasal Decongestant
  • ASK DOCTOR

    Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for two weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
  • ASK DOCTOR

    Ask your doctor before use if you have

    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • glaucoma
    • trouble urinating due to enlarged prostrate gland
    • cough that occurs with to much phlegm (mucus)
    • chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • WHEN USING

    When using this product

    • do not exceed recommended dosage
    • may cause excitability especially in children
    • may cause drowsiness: alcohol, sedatives,tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery

  • STOP USE

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache.  These may be symptoms of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Uses temporarily relieves these symptoms due to cold, hay fever or other upper respiratory allergies
    • runny nose, sneezing, itching of the nose or throat, and itchy watery eyes
    • cough due to minor throat and bronchial irritation
    • nasal congestion
  • QUESTIONS

    Questions? Reports of serious side effects
    associated with use of the product call 787-832-6645.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    BRONKIDS 
    chlorpheniramine/dextromethorphan/phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (STRAWBERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49963-210-04118 mL in 1 BOTTLE, PLASTIC
    2NDC:49963-210-0130 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2009
    Labeler - Portal Pharmaceutical (831005199)
    Registrant - Elge Inc (610655136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elge Inc610655136manufacture
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