Ed A-hist Liquid

SPL v8

SPL

SPL Set ID bf5c4a23-9581-4b84-a75b-e17e1d768970

Route

ORAL

Published

Effective Date 2011-03-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Phenylephrine (10 mg)

Inactive Ingredients

Glycerin Water Sodium Citrate Saccharin Sodium Sorbitol Propylene Glycol Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2011-01-11

Description

Active ingredients (in each 5 mL teaspoonful) Chlorpheniramine Maleate 4mg Phenylephrine Hydrochloride 10 mg Alcohol.............................................5%

Purpose

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

Medication Information

Purpose

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

Description

Active ingredients (in each 5 mL teaspoonful) Chlorpheniramine Maleate 4mg Phenylephrine Hydrochloride 10 mg Alcohol.............................................5%

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.

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.

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4mg

Phenylephrine Hydrochloride 10 mg

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

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.

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.

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

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.

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.

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.

Warnings: Do Not Exceed Recommended Dosage.

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

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

Structured Label Content

Uses

Purpose

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

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

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Chlorpheniramine Maleate 4mg

Phenylephrine Hydrochloride 10 mg

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

Product Packaging

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

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.

Other Information: (Other information:)

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients: (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? (Questions or comments?)

Call 1-800-543-9560

Iss. 12/10

When Using the Product (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.

Do Not Use This Product (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.

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Warnings: Do Not Exceed Recommended Dosage. (Warnings: Do not exceed recommended dosage.)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Do Not Take This Product, Unless Directed By A Doctor Before Use If You Have (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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.", "Purpose": "Antihistamine.........................Nasal Decongestant", "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.", "Drug Facts": "Active ingredients (in each 5 mL teaspoonful) Chlorpheniramine Maleate 4mg Phenylephrine Hydrochloride 10 mg Alcohol.............................................5%", "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. 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.", "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", "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.", "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.", "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.", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers.", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.821356 · Updated: 2026-03-14T23:13:20.000214