Ed A-hist Dm Tablets

Ed A-hist Dm Tablets
SPL v1
SPL
SPL Set ID ca13b8c2-022b-4eab-a573-8e4a65e33130
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) Dextromethorphan (10 mg) Phenylephrine
Inactive Ingredients
Lactose Monohydrate Microcrystalline Cellulose Magnesium Stearate Hypromellose, Unspecified Propylene Glycol Titanium Dioxide D&c Red No. 27 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: ED;DM Shape: oval Color: purple Size: 16 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 respiratory allergies:

  • runny nose.
  • sneezing.
  • itching of the nose or throat.
  • itchy, watery eyes.
  • cough due to minor throat and bronchial irritation.
  • 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

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

Section 50569-3

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

  • a breathing problem such as emphysema or chronic bronchitis.
  • glaucoma.
  • a persistent or chronic cough that occurs with too much phlegm (mucus).
  • heart disease.
  • high blood pressure.
  • thyroid disease.
  • diabetes mellitus.
  • difficulty in urination due to enlargement of the prostate gland.
Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1
Active Ingredients (in each tablet) Purpose
Chlorpheniramine Maleate 4 mg Antihistamine
Dextromethorphan HBr 10 mg Antitussive
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 in 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, Titanium Dioxide, D&C Red #27, Blue #1.

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 marked drowsiness.
  • sedatives and tranquilizers may increase 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.
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur.
Package Label.principal Display Panel

NDC 66576-240-01

ED A-HIST DM TABLETS

Antihistamine • Antitussive • Nasal Decongestant

Each tablet contains:

Chlorpheniramine Maleate .............. 4 mg

Dextromethorphan HBr.................. 10 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 respiratory allergies:

  • runny nose.
  • sneezing.
  • itching of the nose or throat.
  • itchy, watery eyes.
  • cough due to minor throat and bronchial irritation.
  • 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)

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

Section 50569-3 (50569-3)

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

  • a breathing problem such as emphysema or chronic bronchitis.
  • glaucoma.
  • a persistent or chronic cough that occurs with too much phlegm (mucus).
  • heart disease.
  • high blood pressure.
  • thyroid disease.
  • diabetes mellitus.
  • difficulty in urination due to enlargement of the prostate gland.
Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active Ingredients (in each tablet) Purpose
Chlorpheniramine Maleate 4 mg Antihistamine
Dextromethorphan HBr 10 mg Antitussive
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 in 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, Titanium Dioxide, D&C Red #27, Blue #1.

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 marked drowsiness.
  • sedatives and tranquilizers may increase 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.
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 66576-240-01

ED A-HIST DM TABLETS

Antihistamine • Antitussive • Nasal Decongestant

Each tablet contains:

Chlorpheniramine Maleate .............. 4 mg

Dextromethorphan HBr.................. 10 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

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