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

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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:

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

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.

Directions


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

Container Label


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: 12/2010 Silarx Pharmaceuticals, Inc