ED A-HIST

Manufacturer: Edwards Pharmaceuticals, Inc.
Effective date: 2025-10-28
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:41:32

Label at a glance#

ProductED A-HIST

Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period Children 6 to under 12 years of age: 1/2 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period Children under 6 years of age: Consult a Doctor A special measuring device should be used to give an accurate dose of this produ...

Storage and handling

Store at 59° - 86°F (15° - 30°C)

Contacts and useful links#

PhoneLabel contact1-800-543-9560

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4mg

Phenylephrine Hydrochloride 10 mg

Alcohol.............................................5%

Purpose

OTC - PURPOSE SECTION

Antihistamine.........................Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Warnings: Do not exceed recommended dosage.

WARNINGS SECTION

Do not use this product

OTC - DO NOT USE SECTION

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

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

OTC - DO NOT USE SECTION

A breathing problem such as emphysema or chronic bronchitis
Glaucoma, heart disease, diabetes, high blood pressure or thyroid disease
Difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using the product

OTC - WHEN USING SECTION

May cause drowsiness
Avoid alcoholic beverages
Alcohol, sedatives, and tranquilizers may increase drowsiness
Be careful when driving a motor vehicle or operating machinery
Excitability may occur, especially in children.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Nervousness, dizziness, or sleeplessness occurs
Symptoms do not improve within 7 days or are accompanied by a fever.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age:	1/2 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period
Children under 6 years of age:	Consult a Doctor

A special measuring device should be used to give an accurate dose of this product to children under 12 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information:

STORAGE AND HANDLING SECTION

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

FD and C Blue #1, Grape Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and FD and C Red #40.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-543-9560

Iss. 12/10

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 0485-0155-16
ED A-HIST LIQUID
ANTIHISTAMINE / DECONGESTANT
Each 5 mL (one teaspoonful) for oral administration contains:
Chlorpheniramine Maleate..............................4 mg
Phenyleprhing Hydrochloride.........................10 mg
Alcohol USP.....................................................5%

GLUTEN FREE / SUGAR FREE

DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

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

Net Contents: 1 pint (473 mL)

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

dispense in a tight, light-resistant container with a child-resistant closure.

This bottle is not to be dispensed to consumer.

label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1086463	Chlorpheniramine/Phenylephrine (Oral Liquid)	chlorpheniramine maleate 0.8 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1086463	chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution	PSN	8
1086463	chlorpheniramine maleate 0.8 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution	SCD	8
1086463	chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORPHENIRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0304850155164	GTIN-13: 0304850155164 EAN-13: 0304850155164 GTIN-12: 304850155164 UPC-A: 304850155164 GTIN storage (14 digits): 00304850155164	ed-ahist.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0485-0155-16	ED A-HIST	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0485-0155-16	ML - Milliliter	0485-0155	44798429-9546-4367-9048-94dcfa2c710c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Chlorpheniramine Maleate	ACTIVE INGREDIENT	V1Q0O9OJ9Z	2
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	2
Chlorpheniramine	ACTIVE MOIETY	3U6IO1965U	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	2
Alcohol	INACTIVE INGREDIENT	3K9958V90M	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	2
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

ED A-HIST
Chlorpheniramine/Phenylephrine
GLYCERIN
WATER
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL
PROPYLENE GLYCOL
ALCOHOL
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0485-0155	0485-0155-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
ALCOHOL	3K9958V90M	IACT
CHLORPHENIRAMINE MALEATE	V1Q0O9OJ9Z	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2024-12-26	full-release	2026-06-01 00:49:17

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 ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL	53460 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL	29008 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL	3 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL	3563 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL	29008 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL	53460 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL	3 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL	2400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL	3563 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL	2400 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ED A-HIST	CHLORPHENIRAMINE/PHENYLEPHRINE	Edwards Pharmaceuticals, Inc.	bf5c4a23-9581-4b84-a75b-e17e1d768970	2025-10-28	Warnings	Exact identifier ndc (package): 0485-0155-16 ndc (product): 0485-0155 ndc11 (package): 00485015516 spl id: 423e4fde-affe-b593-e063-6394a90aa884 spl set id: bf5c4a23-9581-4b84-a75b-e17e1d768970

Reported adverse events (FAERS/openFDA)#

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