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Drug Facts
Ed-a-hist Dm Tablet, Coated
FDA Label NDC 0485-0240
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Edwards Pharmaceuticals, Inc. for the product Ed-a-hist Dm (NDC 0485-0240). 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
Otc - Purpose
| Active Ingredients (in each tablet) | Purpose |
|---|---|
| Chlorpheniramine Maleate 4 mg | Antihistamine |
| Dextromethorphan HBr 10 mg | Antitussive |
| Phenylephrine HCl 10 mg | Nasal 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
Lake blend purple, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-800-543-9560 Rev. 08/14
Principal Display Panel - 100 Tablet Bottle Label
NDC 0485-0240-01
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.
Ripley, MS 38663
100 tablets
Principal Display Panel (100 Tablet Bottle Label)
* Please review the disclaimer below.
