BRONKIDS - chlorpheniramine/dextromethorphan/phenylephrine 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

When using this product


Stop use and ask a doctor if

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-210
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 HYDROBROMIDE15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (STRAWBERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49963-210-04118 mL in 1 BOTTLE, PLASTIC
2NDC:49963-210-0130 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2009
Labeler - Portal Pharmaceutical (831005199)
Registrant - Elge Inc (610655136)
Establishment
NameAddressID/FEIBusiness Operations
Elge Inc610655136manufacture

Revised: 1/2010
Document Id: a2c5b8a8-e7ca-4e6c-9432-538ca8294077
Set id: 5488d81a-5a49-44f9-b16b-1cb55c35b175
Version: 1
Effective Time: 20100104
 
Portal Pharmaceutical