FDA.reportPublic FDA data

ED A-HIST TABLETS

Manufacturer
EDWARDS PHARMACEUTICALS, INC.
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:35:42

Label at a glance#

ProductED A-HIST
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets is 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each tablet)Purpose
Chlorpheniramine Maleate 4 mgAntihistamine
Phenylephrine HCl 10 mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

WARNINGS SECTION

  • Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by a fever
  • new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets is 24 hours, or as directed by a doctor
Children under 6 years of age:Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate. Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-543-9560 Rev.

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0485-0254-01

ED A-HIST TABLETS

Antihistamine • Nasal Decongestant

Each tablet contains:
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 38663

100 tablets

Principal Display Panel - 100 Tablet Bottle Label
Principal Display Panel - 100 Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090443chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSN4
1090443chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0485-0254-012024-11-08C16284748780-19d75b9d0-5bf6-f424-e053-dadaa90a57ceED A-HIST TABLETS
0485-0254-012023-07-28C16284748780-19d75b9d0-5bf6-f424-e053-dadaa90a57ceED A-HIST TABLETS
0485-0254-012020-04-08C16284748780-19d75b9d0-5bf6-f424-e053-dadaa90a57ceED A-HIST TABLETS
0485-0254-012020-01-31C16284748780-19d75b9d0-5bf6-f424-e053-dadaa90a57ceED A-HIST TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0485-0254-01ED A-HIST100 in 1 BOTTLE, PLASTICTABLET, COATED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0485-0254ED A-HIST (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20241109_9147416d-9f3d-4ee4-a0c0-723e29830325.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0485-0254-01EA - Each0485-0254fc297843-6e8d-4902-887f-775f2c7091b712013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6B1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0485-02540485-0254-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

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 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, COATED / ORAL3.17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, COATED / ORAL3.17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, COATED / ORAL7.93 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, COATED / ORAL7.93 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
2 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 A-HISTCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.9147416d-9f3d-4ee4-a0c0-723e298303252024-11-07WarningsExact identifier
ndc (package): 0485-0254-01
ndc (product): 0485-0254
ndc11 (package): 00485025401
spl id: 265d5942-08d4-74ae-e063-6394a90a5e90
spl set id: 9147416d-9f3d-4ee4-a0c0-723e29830325

Reported adverse events (FAERS/openFDA)#

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