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Bronkids by Portal Pharmaceutical

Medically reviewed on October 9, 2017

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 0.6mg in 1mL, Phenylephrine Hydrochloride 1.5mg in 1mL, Dextromethorphan Hydrobromide 2.75mg in 1mL
Labeler: Portal Pharmaceutical
NDC Code: 49963-118

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 Oral Drops

Drug Facts Active ingredients                                                     
(in each 1 mL dropperful)

Chlorpheniramine Maleate 0.6 mg
Dextromethorphan Hydrobromide 2.75 mg
Phenylephrine Hydrochloride 1.5 mg

Antihistamine
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
  • in a child who is taking a prescription monoamine 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a cough that lasts or is chronic such as occurs with asthma
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition
  • new symptoms occur

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

Directions Administer using provided dropper.
Do not exceed recommended dosage.
Children 6 to under
12 years of age:
3 dropperfuls every 4 hours.  Not to
exceed 18 dropperfuls in 24 hours.
Children under 6 years
of age:
Consult a physician


Other informationStore at 20°-25°C (68°-77°F)
Excursions permitted to 15°-30°C (59°-86°F)

Inactive ingredientsFD&C Blue #1, Fruit Gum Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?Call 1-787-832-6645
Serious side effects associated with use of this product may be reported to this number.

Product PackagingPackaging below represents the labeling currently used.

Principal display panel and side panel for 30 mL label:

NDC 49963-118-01

Antihistamine / Antitussive / Nasal Decongestant
Sugar Free / Alcohol Free

Bronkids Oral Drops

DELICIOUS BUBBLE GUM FLAVOR!

Each 1 mL (dropperful) for oral administration contains:

Chlorpheniramine Maleate.......................0.6 mg
Dextromethorphan HBr..........................2.75 mg
Phenylephrine HCl..................................1.5 mg

1 fl oz (30 mL)

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

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

Rev. 02/12

Manufactured for:
PORTAL Pharmaceutical
Mayaguez, PR  00680












BRONKIDS  
chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-118
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate0.6 mg  in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride1.5 mg  in 1 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide2.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49963-118-011 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/03/2007
Labeler - Portal Pharmaceutical (831005199)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIOperations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(49963-118)

 
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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