FDA LABEL GENERIC: Chlorpheniramine MFR: Portal Pharmaceutical

Chlorpheniramine Maleate 0.6 Mg / Dextromethorphan Hbr 2.75 Mg / Phenylephrine Hcl 1.5 Mg In 1 Ml Oral Solution

Table of Contents

Drug Facts
Uses
Warnings
Directions
Other information
Inactive ingredients
Questions? Comments?
Product Packaging

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

Uses

temporarily 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 information

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

Inactive ingredients

FD&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 Packaging

Packaging 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