ED A-HIST DM DEXTROMETHORPHAN HYDROBROMIDE CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE EDWARDS PHARMACEUTICALS, INC. FDA Approved 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
FunFoxMeds bottle
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each 5 mL teaspoonful) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Dextromethorphan HBr 15 mg Antitussive Phenylephrine HCl 10 mg Nasal Decongestant
Inactive Ingredients
Inactive ingredients Artificial and Natural Banana Flavor Citric Acid FD&C Red #40 FD&C Yellow #6 Methyl Paraben Propyl Paraben Propylene Glycol Purified Water Sodium Citrate Sucralose.
Strengths
5 ml 4 mg 15 mg 10 mg
Quantities
473 ml 5 ml
Treats Conditions
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
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0304850171164
UNII
V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ
Packaging

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) EdHist0171

Package Descriptions
  • 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) EdHist0171

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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. 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 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 If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
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

Do Not Use

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

When Using

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 & Ask a Doctor

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

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.

Storage & Handling

Other information Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Questions

Question? Comments? Call 1-800-543-9560


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