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Pedia Relief by Proficient Rx LP

Medically reviewed on April 2, 2018

Dosage form: liquid
Ingredients: Chlorpheniramine maleate 1mg in 5mL, Pseudoephedrine hydrochloride 15mg in 5mL, Dextromethorphan hydrobromide 5mg in 5mL
Labeler: Proficient Rx LP
NDC Code: 63187-688

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

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.

Active ingredient

Chlorpheniramine maleate 1 mg . . . . . . . . . . . . . . . . . Antihistamine
Pseudoephedrine hydrochloride 15 mg . . . . . . . . . . . . Nasal Decongestant
Dextromethorphan hydrobromide 5 mg . . . . . . . . . . . . Cough Suppressant

Purpose

Chlorpheniramine maleate 1 mg . . . . . . . . . . . . . . . . . Antihistamine
Pseudoephedrine hydrochloride 15 mg . . . . . . . . . . . . Nasal Decongestant
Dextromethorphan hydrobromide 5 mg . . . . . . . . . . . . Cough Suppressant

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 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

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

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

PEDIA RELIEF 
chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-688(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:63187-688-04120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/1997
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-688)

 
Proficient Rx LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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