BRONKIDS- chlorpheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid

Bronkids by

Drug Labeling and Warnings

Bronkids by is a Otc medication manufactured, distributed, or labeled by Portal Pharmaceutical, Pernix Manufacturing, LLC, Pernix Manufacturing, LLC dba Great Southern Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 under12 years of age: 3 dropperfuls every 4 hours. Not to; exceed 18 dropperfuls in 24 hours.
• Children under 6 yearsof 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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	0.6 mg  in 1 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	1.5 mg  in 1 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	2.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49963-118-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

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)

Registrant - Pernix Manufacturing, LLC (078641814)

Establishment
Name	Address	ID/FEI	Business Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories		078641814	manufacture(49963-118)