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ED-A-HIST PSE (EDWARDS PHARMACEUTICALS, INC.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01) Label Information

Complete ED-A-HIST PSE Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet) Purpose
    Pseudoephedrine HCI 60 mg Nasal 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

    Principal Display Panel - 100 Tablet Bottle Label

  • INGREDIENTS AND APPEARANCE
    ED-A-HIST PSE 
    pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0210
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Color GREEN Score 2 pieces
    Shape OVAL Size 13mm
    Flavor Imprint Code ED;PSE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0485-0210-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/08/2011
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)