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

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

BRONKIDS (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PORTAL PHARMACEUTICAL]
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NDC 49963-118-01
Set ID 12e5b41b-6a30-456c-9242-45fe7e9e45d8
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 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)
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