Pediatric Cough & Cold Medicine

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:

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 yearsDO 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 TypeHUMAN OTC DRUGNDC Product Code (Source)54838-115
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine maleate (Chlorpheniramine) Chlorpheniramine maleate1 mg  in 5 mL
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride15 mg  in 5 mL
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
FD&C red no. 40 
glycerin 
propylene glycol 
sodium benzoate 
sodium citrate 
sorbitol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (wild cherry flavor) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
154838-115-40120 mL In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/1997

Labeler - Silarx Pharmaceuticals, Inc (161630033)
Revised: 06/2010Silarx Pharmaceuticals, Inc