Ed A-hist Tablets

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Phenylephrine (10 mg)

Inactive Ingredients

Fd&c Blue No. 2 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance

Imprint: E;1 Shape: oval Color: brown Size: 13 mm Score: 2

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2011-10-08

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50568-5

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active Ingredients (in each tablet)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Directions

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

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?

Call 1-800-543-9560 Rev.

Do Not Use This Product

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.

When Using This Product

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

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

Ask A Doctor Before Use If You Have

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

Principal Display Panel 100 Tablet Bottle Label

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

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active Ingredients (in each tablet)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Directions

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 ingredients)

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? (Questions or Comments?)

Call 1-800-543-9560 Rev.

Do Not Use This Product (Do not use this product)

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.

When Using This Product (When using this product)

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 (Stop use and ask a doctor if)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Principal Display Panel 100 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant", "Warnings": "Do not exceed recommended dosage.", "Directions": "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": "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?": "Call 1-800-543-9560 Rev.", "Do not use this product": "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.", "When using this product": "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": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur", "Ask a doctor before use if you have": "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", "PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label": "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information