Bronkids Liquid

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
(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4 mg
Dextromethrophan 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:

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
Dextromethrophan 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




BRONKIDS 
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-532
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate4 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:49963-532-04118 mL in 1 BOTTLENone
2NDC:49963-532-0130 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/10/2011

Labeler - Portal Pharmaceutical (831005199)

Revised: 11/2011 Portal Pharmaceutical