BRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]

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  • BRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]

BRONKIDS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]
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NDC 49963-532-01, 49963-532-04
Set ID 11943d27-da4d-44ec-b0e7-e468e18d2b6c
Category HUMAN OTC DRUG LABEL
Packager Portal Pharmaceutical
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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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