ED A-HIST DM description, usages, side effects, indications, overdosage, supplying and lots more!

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ED A-HIST DM

EDWARDS PHARMACEUTICALS, INC.

ED A-HIST DM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

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

ED A-HIST DM 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.

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.

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.

ED A-HIST DM 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)

ED A-HIST DM

ED A-HIST DM

DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0485-0171
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
sorbitol
Sucralose

Product Characteristics

Color
YELLOW

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0485-0171-16 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-09-11


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Be sure to consult your doctor before taking any medication!
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