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Drug Facts
Ed A-hist Dm Liquid
FDA Label NDC 0485-0171
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 0485-0171). 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, when using this product, stop use and ask doctor if, otc - pregnancy or breast feeding, 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 5 mL teaspoonful) | Purpose |
|---|---|
| Chlorpheniramine Maleate 4 mg | Antihistamine |
| Dextromethorphan HBr 15 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.
- 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
Do not use this product, unless directed by a doctor, if you have
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 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 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age: | 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children under 6 years of age: | Consult a doctor. |
Other Information
Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].
Inactive Ingredients
Banana Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.
Question? Comments?
Call 1-800-543-9560
Principal Display Panel - 473 Ml Bottle Label
E
NDC 0485-0171-16
ED A-HIST DM
Antihistamine • Antitussive
• Nasal Decongestant
Sugar Free • Gluten Free
Each teaspoonful (5 mL)
for oral administration contains:
Chlorpheniramine Maleate 4 mg
Dextromethorphan HBr 15 mg
Phenylephrine HCl 10 mg
Banana Flavor
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
16oz. (473 mL)
Principal Display Panel (473 mL Bottle Label)
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