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Name:Bronkids
Manufacturer:Portal Pharmaceutical
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BRONKIDS  - chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Portal Pharmaceutical

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.

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Drug Facts

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

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 a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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 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 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.

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

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

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

image of label


BRONKIDS 
chlorpheniramine/dextromethorphan/phenylephrine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49963-210
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40  
GLYCERIN  
PROPYLENE GLYCOL  
WATER  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY (STRAWBERRY) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49963-210-04 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:49963-210-01 30 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/01/2009

Labeler - Portal Pharmaceutical (831005199)
Registrant - Elge Inc (610655136)
Establishment
Name Address ID/FEI Operations
Elge Inc 610655136 manufacture

Revised: 01/2010 Portal Pharmaceutical



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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