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Pedia Relief

Major Pharmaceuticals, Inc
Silarx Pharmaceuticals, Inc

Pedia Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Uses

temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies:

  • nasal congestion
  • runny nose
  • sneezing
  • cough

Warnings

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts such as occurs with asthma

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

When using this product your child may

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign 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 6 hours
  • Do not exceed 4 doses in 24 - hour period.

AGE
DOSE
Children 6 to under 11 years
2 teaspoonfuls
Children under 6 years DO NOT USE

Pedia Relief Other information

Store at room temperature.

Inactive ingredients

citric acid, FD&C red no. 40, wild cherry flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol.

Adverse Drug Event Call:

(800) 616-2471

Distributed By:

Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150


Pedia Relief


Pedia Relief


Pedia Relief

Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5050
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:0904-5050-20 120 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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