BRONKIDS  - chlorpheniramine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid 
Portal Pharmaceutical

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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  chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49963-118-01 1 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: 06/2010Portal Pharmaceutical