Ed-a-hist Dm
FDA Label NDC 66576-240

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Syntho Pharmaceuticals, Inc. for the product Ed-a-hist Dm (NDC 66576-240). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use this product, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active Ingredients (in each tablet)Purpose
Chlorpheniramine Maleate 4 mgAntihistamine
Dextromethorphan HBr 10 mgAntitussive
Phenylephrine HCl 10 mgNasal Decongestant

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.

Warnings

  • Do not exceed recommended dosage.

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.

Otc - Ask Doctor

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.

Otc - Ask Doctor/Pharmacist

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

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

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

Image Description (Ed A Hist Dm Ndc 66576 240 01)

Image Description (Ed A Hist Dm Ndc 66576 240 01)

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