Pediatric Cough and Cold Medicine

Silarx Pharmaceuticals, Inc

Pediatric Cough & Cold Medicine

FULL PRESCRIBING INFORMATION: CONTENTS*

• Warnings
• Directions
• Pediatric Cough and Cold Medicine Other information
• Inactive ingredients
• Questions

FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient: Chlorpheniramine maleate 1 mg (in each 5 mL)

Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL)

Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL)

Purpose

Purpose of Chlorpheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Purpose of Dextromethorphan hydrobromide: Cough Suppressant

Uses

Uses temporarily relieves common cold, hay fever or other upper respiratory allergy symptoms:

• nasal congestion
  
• runny nose
  
• sneezing
  
• cough

Warnings

Do not exceed recommended dosage.

Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• heart diseases
  
• high blood pressure
  
• thyroid disease
  
• diabetes
  
• glaucoma
  
• asthma
  
• a breathing problem or a persistent or chronic cough
  
• excessive phlegm (mucus)
  
• cough that occurs with too much phlegm (mucus)
  
• chronic bronchitis

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

When using this product your child may

• become easily excited
  
• get drowsy
  
• sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
  
• symptoms do not improve within 7 days or are accompanied by fever
  
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  

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

Directions

• Dose may be repeated every 4 to 6 hours or as directed by a doctor
  
• Do not exceed 4 doses in 24 - hour period.

Pediatric Cough and Cold Medicine Other information

Store at room temperature 20°-25°C (68°-77°F). Do not use if tamper-evident band around cap is broken or missing.

Inactive ingredients

citric acid, FD&C red no. 40, wild cherry flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol.

Questions

888-974-5279