Label: BRONKIDS- chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide 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 October 8, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active ingredients                                                     
    (in each 1 mL dropperful)
    Chlorpheniramine Maleate 0.6 mg
    Dextromethorphan Hydrobromide 2.75 mg
    Phenylephrine Hydrochloride 1.5 mg

    Antihistamine
    Antitussive
    Nasal Decongestant
  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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 pharmacist before giving this product.

    Ask a doctor before use if the child has

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

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedatives and tranquilizers may increase the drowsiness effect

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition
    • new symptoms occur

    Keep out of reach of children.

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

    Administer using provided dropper.
    Do not exceed recommended dosage.
    Children 6 to under
    12 years of age:
    		3 dropperfuls every 4 hours.  Not to
    exceed 18 dropperfuls in 24 hours.
    Children under 6 years
    of age:
    		Consult a physician

  • Other information

    Store at 20°-25°C (68°-77°F)
    Excursions permitted to 15°-30°C (59°-86°F)
  • Inactive ingredients

    FD&C Blue #1, Fruit Gum Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
  • Questions? Comments?

    Call 1-787-832-6645
    Serious side effects associated with use of this product may be reported to this number.
  • Product Packaging

    Packaging below represents the labeling currently used.

    Principal display panel and side panel for 30 mL label:

    NDC 49963-118-01

    Antihistamine / Antitussive / Nasal Decongestant
    Sugar Free / Alcohol Free

    Bronkids Oral Drops

    DELICIOUS BUBBLE GUM FLAVOR!

    Each 1 mL (dropperful) for oral administration contains:

    Chlorpheniramine Maleate.......................0.6 mg
    Dextromethorphan HBr..........................2.75 mg
    Phenylephrine HCl..................................1.5 mg

    1 fl oz (30 mL)

    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing.

    Supplied in a tight, light-resistant container
    with a child-resistant cap.

    Rev. 02/12

    Manufactured for:
    PORTAL Pharmaceutical
    Mayaguez, PR  00680



    Bronkids Oral Drops Packaging



    Bronkids Oral Drops Packaging



    Bronkids Oral Drops Packaging



  • INGREDIENTS AND APPEARANCE
    BRONKIDS  
    chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate0.6 mg  in 1 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride1.5 mg  in 1 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide2.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49963-118-011 in 1 CARTON
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/03/2007
    Labeler - Portal Pharmaceutical (831005199)
    Registrant - Pernix Manufacturing, LLC (078641814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(49963-118)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!