Pediatric Cough and Cold Medicine description, usages, side effects, indications, overdosage, supplying and lots more!

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Pediatric Cough and Cold Medicine

Silarx Pharmaceuticals, Inc

Pediatric Cough & Cold Medicine


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose of Chlorpheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Purpose of Dextromethorphan hydrobromide: Cough Suppressant

Uses

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 years DO NOT USE

Pediatric Cough and Cold Medicine 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

Pediatric Cough and Cold Medicine

Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54838-115
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
propylene glycol
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-115-40 120 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1997-01-05


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Be sure to consult your doctor before taking any medication!
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