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Pedia Relief by Preferred Pharmaceuticals Inc.

Medically reviewed on December 5, 2017

Dosage form: liquid
Ingredients: Chlorpheniramine maleate 1mg in 5mL, Pseudoephedrine hydrochloride 15mg in 5mL, Dextromethorphan hydrobromide 5mg in 5mL
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-6337

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.

PEDIA RELIEF™

Drug Facts

Active ingredients (in each 2 TSP (10 mL))Purposes

Chlorpheniramine maleate, USP 2 mg

Antihistamine

Dextromethorphan HBr, USP 10 mg

Cough suppressant

Pseudoephedrine HCl, USP 30 mg

Nasal decongestant

Uses

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

1.
cough
2.
nasal congestion
3.
runny nose
4.
sneezing
5.
itching of the nose or throat
6.
itchy, watery eyes

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
1.
a breathing problem such as chronic bronchitis
2.
cough that occurs with too much phlegm (mucus)
3.
chronic cough that lasts such as occurs with asthma
4.
heart disease
5.
thyroid disease
6.
glaucoma
7.
diabetes
8.
high blood pressure

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

When using this product
1.
do not use more than directed
2.
drowsiness may occur
3.
excitability may occur, especially in children
4.
sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if
1.
cough lasts for 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.
2.
the child gets nervous, dizzy or sleepless
3.
symptoms do not get better within 7 days or occur with fever

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
1.
dose may be repeated every 6 hours
2.
do not exceed 4 doses in a 24-hour period
3.
use enclosed dosing cup only. Do not use with any other device.
AGEDOSE

Children 6 to 11 years

2 TSP

Children under 6 years

Do not use

Other information
1.
store at 20° - 25°C (68° - 77°F)

Inactive ingredients

artificial cherry flavor, citric acid, FD&C red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

1-800-616-2471

Distributed by:
Major Pharmaceuticals
17177 N Laurel Park Drive,
Suite 233,
Livonia, MI 48152

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 68788-6337-1

MAJOR®

Pedia
Relief

Cough-Cold
Oral Solution

Relief For

1.
Coughs
2.
Runny
Nose
3.
Stuffy
Nose

ALCOHOL FREE

Antihistamine
Cough Suppressant
Nasal Decongestant

4 FL OZ (118 mL)

Repackaged By: Preferred Pharmaceuticals Inc.

PEDIA RELIEF 
chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6337(NDC:0904-5050)
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, UNSPECIFIED FORM 
sorbitol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (wild cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-6337-1120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/17/2016
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-6337)

 
Preferred 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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