Bronkids Oral Drops

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Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                                     
(in each 1 mL dropperful)
Chlorpheniramine Maleate 0.6 mg
Dextromethorphan Hydrobromide 2.75 mg
Phenylephrine Hydrochloride 1.5 mg

OTC - PURPOSE SECTION

Antihistamine
Antitussive
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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
  

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions? Comments?

OTC - QUESTIONS SECTION

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

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

• Bronkids
• Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
• Chlorpheniramine Maleate
• Chlorpheniramine
• Phenylephrine Hydrochloride
• Phenylephrine
• Dextromethorphan Hydrobromide
• Dextromethorphan
• Glycerin
• Propylene Glycol
• Water
• Sodium Citrate
• Saccharin Sodium
• Sorbitol

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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Inactive ingredient links page 1 of 4 · 234 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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