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Pediatric Cough and Cold Medicine

Medically reviewed on June 26, 2017

Dosage form: liquid
Ingredients: Chlorpheniramine maleate 1mg in 5mL, Pseudoephedrine hydrochloride 15mg in 5mL, Dextromethorphan hydrobromide 5mg in 5mL
Labeler: Silarx Pharmaceuticals, Inc
NDC Code: 54838-115

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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:

  • 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 (TSP)
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

PEDIATRIC COUGH AND COLD MEDICINE 
chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: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
#Item CodePackage Description
1NDC:54838-115-40120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/1997
Labeler - Silarx Pharmaceuticals, Inc (161630033)

 
Silarx Pharmaceuticals, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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