BRONKIDS- chlorpheniramine/dextromethorphan/phenylephrine liquid

Bronkids by

Drug Labeling and Warnings

Bronkids by is a Otc medication manufactured, distributed, or labeled by Portal Pharmaceutical, Elge Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

ASK DOCTOR

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 DOCTOR/PHARMACIST

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

ASK DOCTOR

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

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

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.
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONKIDS 
chlorpheniramine/dextromethorphan/phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49963-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	STRAWBERRY (STRAWBERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49963-210-04	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 49963-210-01	30 mL in 1 BOTTLE, PLASTIC

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	Business Operations
Elge Inc		610655136	manufacture