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


Pediatric Cough & Cold Medicine

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 of Chlorpheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Purpose of Dextromethorphan hydrobromide: Cough Suppressant

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


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

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

When using this product your child may

Stop use and ask a doctor if

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


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.



Container Label

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  
propylene glycol  
sodium benzoate  
sodium citrate  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (wild cherry flavor) Imprint Code
# 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: 12/2010 Silarx Pharmaceuticals, Inc