PEDIA RELIEF- chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid

Pedia Relief by

Drug Labeling and Warnings

Pedia Relief by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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:

• cough
• nasal congestion
• runny nose
• sneezing
• itching of the nose or throat
• 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

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

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

When using this product

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

Stop use and ask a doctor if

• 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.
• the child gets nervous, dizzy or sleepless
• 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

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

AGE	DOSE
Children 6 to 11 years	2 TSP
Children under 6 years	Do not use

Other information

• 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

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC: 0904-5050-20

MAJOR®

Pedia
Relief ™

Cough-Cold
Oral Solution

Relief For

• Coughs
• Runny
  Nose
• Stuffy
  Nose

ALCOHOL FREE

Antihistamine
Cough Suppressant
Nasal Decongestant

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

PEDIA RELIEF 
chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (wild cherry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5050-20	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/1997	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/05/1997	09/30/2020

Labeler - Major Pharmaceuticals, Inc (191427277)