Pedia Relief

Manufacturer
Proficient Rx LP
Effective date
2018-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:33:38

Label at a glance#

ProductPedia Relief
Active ingredientChlorpheniramine maleate, Pseudoephedrine hydrochloride, Dextromethorphan hydrobromide
Label structure11 sections

Boxed warning

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.

Dosage and administration

• 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

Label contents#

Full prescribing information#

Warnings

Boxed Warning section

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

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

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

Drug Facts

DESCRIPTION SECTION

Active ingredients (in each 5 mL)                      Purpose

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

INDICATIONS & USAGE SECTION

Uses

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

  • nasal congestion
  • runny nose
  • sneezing
  • cough

Warnings

WARNINGS SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Adverse Drug Event Call:

OTC - QUESTIONS SECTION

(800) 616-2471

Distributed By:

Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63187-688-04
63187-688-04

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5050-20ML - Milliliter0904-505037e80553-69b0-45b2-9938-aef5e7837d1d12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63187-68863187-688-04
0904-5050

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ed3733c1-5360-4397-9d41-d4d6984b8e44b781a162-244d-49b2-8918-031fce0587d72021-01-01Boxed warning, WarningsExact identifier
spl set id: b781a162-244d-49b2-8918-031fce0587d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.