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ED-A-HIST PSE

Medically reviewed on February 27, 2018

Dosage form: tablet, coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg, TRIPROLIDINE HYDROCHLORIDE 2.5mg
Labeler: EDWARDS PHARMACEUTICALS, INC.
NDC Code: 0485-0210

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ED-A-HIST PSE TABLETS

Drug Facts

Active Ingredients (in each tablet)Purpose
Pseudoephedrine HCI 60 mgNasal Decongestant
Triprolidine HCI 2.5 mg.Antihistamine

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • 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.

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, 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
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur

If pregnant or breast-feeding, 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 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1/2 tablet every 4-6 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor
Children under 6 years of age:Consult a doctor.

Inactive ingredients

FD&C Blue #2, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

Questions or Comments?

Call 1-800-543-9560

Rev. 11/11

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 00485-0210-01

ED A-HIST PSE TABLETS

Nasal Decongestant • Antihistamine

Each tablet contains:
Pseudoephedrine HCI       60 mg
Triprolidine HCI                2.5 mg

This bottle is not to be dispensed to consumer.
Dispense in a tight, light-resistant container
with a child-resistant cap.

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

ED-A-HIST PSE 
pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
TRIPROLIDINE HYDROCHLORIDE (TRIPROLIDINE) TRIPROLIDINE HYDROCHLORIDE2.5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
FD&C YELLOW NO. 5 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize13mm
FlavorImprint CodeED;PSE
Contains    
Packaging
#Item CodePackage Description
1NDC:0485-0210-01100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/08/2011
Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

 
EDWARDS PHARMACEUTICALS, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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