Label: ED-A-HIST PSE- pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated

  • NDC Code(s): 0485-0210-01
  • Packager: EDWARDS PHARMACEUTICALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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

    Principal Display Panel - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    ED-A-HIST PSE 
    pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorgreenScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code ED;PSE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0210-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/08/2011
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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