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Bronkids by Portal Pharmaceutical

Medically reviewed on Nov 21, 2017

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 4mg in 5mL, Dextromethorphan Hydrobromide 10mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL
Labeler: Portal Pharmaceutical
NDC Code: 49963-532

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.

Bronkids Liquid

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine Hydrochloride 10 mg

PurposeAntihistamine
Antitussive
Nasal Decongestant

Usestemporarily 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
  • 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 aretaking 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 informationStore at controlled room temperature 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container with a
child-resistant cap.

Inactive ingredientsCitric 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 PackagingThe 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
Dextromethorphan 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 
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 Description
1NDC:49963-532-04118 mL in 1 BOTTLE
2NDC:49963-532-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/10/2011
Labeler - Portal Pharmaceutical (831005199)

 
Portal Pharmaceutical

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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