PEDIATRIC COUGH AND COLD MEDICINE  - chlorpheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid 
Silarx Pharmaceuticals, Inc

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Pediatric Cough & Cold Medicine

Drug Facts

Active ingredients (in each 5 mL)                      Purpose

Chlorpheniramine maleate 1 mg . . . . . . . . . . . . . . . . . Antihistamine
Pseudoephedrine hydrochloride 15 mg . . . . . . . . . . . . Nasal Decongestant
Dextromethorphan hydrobromide 5 mg . . . . . . . . . . . . Cough Suppressant

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.

AGE	DOSE
Children 6 to under 11 years	2 teaspoonfuls
Children under 6 years	DO NOT USE

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

PEDIATRIC COUGH AND COLD MEDICINE  chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-115 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine maleate (Chlorpheniramine) Chlorpheniramine maleate 1 mg  in 5 mL Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride 15 mg  in 5 mL Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength anhydrous citric acid   FD&C red no. 40   glycerin   propylene glycol   sodium benzoate   sodium citrate   sorbitol   water

Product Characteristics Color      Score      Shape Size Flavor CHERRY (wild cherry flavor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54838-115-40 120 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/05/1997

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 06/2010Silarx Pharmaceuticals, Inc