PEDIA RELIEF- chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid 
Major Pharmaceuticals, Inc

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.

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PEDIA RELIEF™

Drug Facts

Active ingredients (in each 2 TSP (10 mL))Purposes
Chlorpheniramine maleate, USP 2 mgAntihistamine
Dextromethorphan HBr, USP 10 mgCough suppressant
Pseudoephedrine HCl, USP 30 mgNasal 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.
AGEDOSE
Children 6 to 11 years2 TSP
Children under 6 yearsDo 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

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)

Principal Display Panel - 118 mL Bottle Label
PEDIA RELIEF 
chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (wild cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5050-20118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/199709/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/199709/30/2020
Labeler - Major Pharmaceuticals, Inc (191427277)

Revised: 9/2019
 
Major Pharmaceuticals, Inc