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Name:Bronkids
Manufacturer:Portal Pharmaceutical
Category:Over-the-counter (OTC) Marketed Drugs


Bronkids Oral Drops

BRONKIDS  - chlorpheniramine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide 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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Bronkids Oral Drops

Drug Facts

Active ingredients                                                      Purpose
(in each 1 mL dropperful)

Chlorpheniramine Maleate 0.6 mg..................................................Antihistamine
Phenylephrine Hydrochloride 1.5 mg..............................................Decongestant
Dextromethorphan Hydrobromide 2.75 mg......................................Antitussive

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • swelling of nasal passages
  • runny nose
  • itchy, watery eyes, sneezing

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are now 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 prescription drug contains a MAOI, ask doctor or pharmacist before taking this product

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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.  These could be signs of a serious condition.
  • new symptoms occur

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.

Directions

Do not exceed recommended dosage.
Children under 6 years
of age:
Consult a physician
Children 6 to 12 years of age:
3 dropperfuls every 4 hours.
Not to exceed 18 dropperfuls in a 24 hour period.

Other information

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

Inactive ingredients

Bubble Gum Flavor, FD and C Blue #1, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call 1-787-832-6645

Product Packaging:

Packaging below represents the labeling currently used:

Principal display panel and side panel for 30 mL label:

NDC 49963-118-01

Antihistamine/Decongestant/Antitussive
Sugar Free/Alcohol Free

Bronkids Oral Drops

DELICIOUS BUBBLE GUM FLAVOR!

Each 1 mL (dropperful) for oral administration contains:

Chlorpheniramine Maleate.......................0.6 mg

Phenylephrine HCl.................................1.5 mg

Dextromethorphan HBr..........................2.75 mg

1 fl oz (30 mL)

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

Supplied with a child-resistant cap.

Rev. 06/10

Manufactured for:
Portal Pharmaceutical
Mayaguez, PR  00680



Bronkids Oral Drops Packaging



Bronkids Oral Drops Packaging



Bronkids Oral Drops Packaging




BRONKIDS 
chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49963-118
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 0.6 mg  in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 1.5 mg  in 1 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 2.75 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49963-118-01 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (49963-118-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/03/2007

Labeler - Portal Pharmaceutical (831005199)

Revised: 06/2010 Portal Pharmaceutical



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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