Label: BRONKIDS- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride 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 November 21, 2011

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  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Chlorpheniramine Maleate 4 mg
    Dextromethorphan Hydrobromide 10 mg
    Phenylephrine Hydrochloride 10 mg

    Purpose

    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

    • if you are taking a prescription monamine 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 taking this product.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • cough or nasal congestion persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition
    • nervousness, dizziness,or sleeplessness occur
    • new symptoms occur

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

    Keep out of reach of children.

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

    Adults and children 12 years
    of age and over


    		1 teaspoonful (5 mL)
    every 4 to 6 hours, not to
    exceed 6 teaspoonfuls
    in 24 hours
    Children 6 to under 12 years
    of age:


    		1/2 teaspoonful (2.5 mL)
    every 4 to 6 hours, not to
    exceed 3 teaspoonfuls
    in 24 hours
    Children under 6 years
    of age:
    		Consult a doctor
  • Other information

    Store at controlled room temperature 15°-30°C (59°-86°F).

    Dispense in a tight, light-resistant container with a
    child-resistant cap.
  • Inactive ingredients

    Citric Acid, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Strawberry Flavor.
  • Questions? Comments?

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

    Rev. 08/11
  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel and side panel for 118 mL label:

    NDC 49963-532-04

    Antihistamine/Antitussive/Nasal Decongestant

    Bronkids
    Liquid

    Strawberry Flavor

    Each 5 mL (one teaspoonful) for
    oral administration contains:
    Chlorpheniramine Maleate.........................4 mg
    Dextromethorphan Hydrobromide.............10 mg
    Phenylephrine Hydrochloride...................10 mg

    Gluten Free

    4 fl oz
    (118 mL)

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

    Manufactured for:
    PORTAL
    Pharmaceutical
    Mayaguez, PR  00680

    Bronkids Liquid Packaging


    Bronkids Liquid Packaging


    Bronkids Liquid Packaging



  • INGREDIENTS AND APPEARANCE
    BRONKIDS 
    chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-532
    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 Hydrobromide10 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid (UNII: 2968PHW8QP)  
    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
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49963-532-04118 mL in 1 BOTTLE
    2NDC:49963-532-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/10/2011
    Labeler - Portal Pharmaceutical (831005199)
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