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NDC 00485-0155-16 ED A-HIST 4; 10 mg/5mL; mg/5mL Details

ED A-HIST 4; 10 mg/5mL; mg/5mL

ED A-HIST is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00485-0155-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 00485-0155-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	00485-0155
Product ID	0485-0155_d57dbed1-1a02-3f9a-e053-2a95a90aaca1
Associated GPIs	43993002300940
GCN Sequence Number	048597
GCN Sequence Number Description	chlorpheniramine/phenylephrine LIQUID 4-10MG/5ML ORAL
HIC3	Z2N
HIC3 Description	1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	14148
HICL Sequence Number	000446
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	ED A-HIST
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorpheniramine/Phenylephrine
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	4; 10
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Edwards Pharmaceuticals, Inc.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00485-0155-16 (00485015516)

Pricing Information
NDC Package Code	0485-0155-16
Billing NDC	00485015516
Package	473 mL in 1 BOTTLE, PLASTIC (0485-0155-16)
Marketing Start Date	2011-01-11
NDC Exclude Flag	N
Price Per Unit	0.04063
Pricing Unit	ML
Effective Date	2021-11-17
NDC Description	ED A-HIST LIQUID
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-16

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL bf5c4a23-9581-4b84-a75b-e17e1d768970 Details

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4mg

Phenylephrine Hydrochloride 10 mg

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

Purpose

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

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.

Warnings: Do not exceed recommended dosage.

Do not use this product

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

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

taking sedatives or tranquilizers.

When using the product

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

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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:

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients:

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?

Call 1-800-543-9560

Iss. 12/10

Product Packaging

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.

Ripley, MS 38663

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.

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