Ed A-hist Tablets

Ed A-hist Tablets
SPL v1
SPL
SPL Set ID a5ab199c-b55c-4166-ba30-fcd0b7a6bb40
Route
ORAL
Published
Effective Date 2022-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg) Phenylephrine (10 mg)
Inactive Ingredients
Lactose Monohydrate Microcrystalline Cellulose Magnesium Stearate Hypromellose, Unspecified Propylene Glycol Tricetin Titanium Dioxide Caramel Riboflavin Ferric Oxide Yellow Fd&c Blue No. 2 Fd&c Yellow No. 6 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Imprint: E;1 Shape: oval Color: brown Size: 13 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-11-02
Description

Drug Facts

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

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, HPMC, Propylene Glycol, Tricetin, Titanium Dioxide, Caramel Color, Riboflavin, Yellow  Oxide, Lake Blend Black

Questions Or Comments?

Call 1-800-664-1490 Rev. 9/22

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 66576 -254-01

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.

Berwyn,PA 19312

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)

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, HPMC, Propylene Glycol, Tricetin, Titanium Dioxide, Caramel Color, Riboflavin, Yellow  Oxide, Lake Blend Black

Questions Or Comments? (Questions or Comments?)

Call 1-800-664-1490 Rev. 9/22

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 66576 -254-01

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.

Berwyn,PA 19312

100 tablets

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:22.077369 · Updated: 2026-03-14T23:00:46.071932