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  5. Label Information: Ed-a-hist Dm

FDA Label for Ed-a-hist Dm

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ed-a-hist Dm Product Label

The following document was submitted to the FDA by the labeler of this product Syntho Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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