ED CHLORPED JR

Manufacturer
EDWARDS PHARMACEUTICALS, INC.
Effective date
2025-10-28
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:41:20

Label at a glance#

ProductED CHLORPED JR
Active ingredientCHLORPHENIRAMINE MALEATE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor .

Storage and handling

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 2 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not take this product, unless directed by a doctor, if you have

OTC - DO NOT USE SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR SECTION

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age and over:2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age:

Consult a doctor

.

Other information

STORAGE AND HANDLING SECTION

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry Flavor, Citric Acid, FD&C Red # 40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

Question? Comments?

OTC - QUESTIONS SECTION

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0485-0098-16

ED Chlorped Jr.

ANTIHISTAMINE

FOR PROFESSIONAL USE ONLY

Sugar Free • Alcohol Free

Each teaspoonful (5 mL)
for oral administration contains:
Chlorpheniramine Maleate 2 mg

Cherry Flavor

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
EDWARDS Pharmaceuticals, Inc.
Paoli, PA 19301

16oz. (473 mL)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363306chlorpheniramine maleate 2 MG in 5 mL Oral SolutionPSN9
1363306chlorpheniramine maleate 0.4 MG/ML Oral SolutionSCD9
1363306chlorpheniramine maleate 2 MG per 5 ML Oral SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130304850098164GTIN-13: 0304850098164
EAN-13: 0304850098164
GTIN-12: 304850098164
UPC-A: 304850098164
GTIN storage (14 digits): 00304850098164
edChlorjr.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0485-0098-042025-10-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042025-10-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162025-10-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162025-10-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042025-07-29C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042025-07-29C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162025-07-29C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162025-07-29C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042024-11-07C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042024-11-07C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162024-11-07C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162024-11-07C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042024-01-30C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042024-01-30C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162024-01-30C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162024-01-30C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042020-04-03C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042020-04-03C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162020-04-03C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162020-04-03C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042020-01-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-042020-01-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162020-01-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.
0485-0098-162020-01-31C16284748780-19d75b9d0-8863-f424-e053-dadaa90a57ceED CHLORPED JR.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0485-0098-04ED CHLORPED JR118 mL in 1 BOTTLE, PLASTICLIQUID1189
0485-0098-16ED CHLORPED JR473 mL in 1 BOTTLE, PLASTICLIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0485-0098-04ML - Milliliter0485-009807fc0916-6f87-4963-872a-76c2c8e1d18412013-04-01
0485-0098-16ML - Milliliter0485-00988e07d008-3e2b-4576-b237-5f3d784a43a612013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FF1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0485-00980485-0098-16, 0485-0098-04

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 · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-01-13full-release2026-06-01 00:35:35

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 180 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route
66 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii+route
66 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route
66 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSUSPENSION / ORALNAExact identifier — unii+route
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
54 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
54 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii+route
66 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii+route
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii+route
66 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSOLUTION / ORAL913 mgExact identifier — unii+route
9 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
66 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFPOWDER, FOR SOLUTION / ORAL570 mgExact identifier — unii+route
9 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
54 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
54 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii+route
36 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii+route
66 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii+route
66 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
66 equally ranked IID candidates

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
ED CHLORPED JRCHLORPHENIRAMINE MALEATEEDWARDS PHARMACEUTICALS, INC.4a5e5968-1930-465a-9b8c-45ed936a0e112025-10-28WarningsExact identifier
ndc (package): 0485-0098-04
ndc (package): 0485-0098-16
ndc (product): 0485-0098
ndc11 (package): 00485009816
ndc11 (package): 00485009804
spl id: 423e5c5d-39b6-c528-e063-6394a90aab81
spl set id: 4a5e5968-1930-465a-9b8c-45ed936a0e11

Reported adverse events (FAERS/openFDA)#

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