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ED CHLORPED D (EDWARDS PHARMACEUTICALS, INC.)

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Dosage Form Package Information Links
LIQUID 60 mL in 1 BOTTLE, DROPPER (0485-0096-02) Label Information

Complete ED CHLORPED D Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredients (in each 1 mL dropperful) Purpose    
    Chlorpheniramine Maleate 2 mg Antihistamine
    Phenylephrine HCl 5 mg Nasal Decongestant

  • 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 in a child who is
    • 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if a child has
    • a breathing problem such as chronic bronchitis
    • glaucoma
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes mellitus

    Ask a doctor before use if a child is taking sedatives or tranquilizers

    When using this product
    • excitability may occur, especially in children
    • may cause drowsiness
    • sedatives and tranquilizers may increase drowsiness effect

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occur
    • new symptoms occur

    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.

    Children 6 to under 12 years of age: 1 mL (1 dropperful) every 4 hours, not to exceed 6 mL in 24 hours or as directed by a doctor
    Children 2 to under 6 years of age: 0.5 mL (1/2 dropperful) every 4 hours, not to exceed 3 mL in 24 hours, or as directed by a doctor
    Children under 2 years of age: Consult a doctor

  • Other information

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


  • Inactive ingredients

    Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose


  • Questions? Comments?

    Call 1-800-543-9560
    Rev. 05/11


  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    E

    NEW
    FORMULA

    NDC 00485-0096-02

    Ed ChlorPed D
    Pediatric Drops

    Antihistamine â–ª Nasal Decongestant
    Sugar Free â–ª Alcohol Free â–ª Gluten Free

    FOR PROFESSIONAL USE ONLY

    Each 1 mL for oral administration
    contains:
    Chlorpheniramine Maleate
    2 mg
    Phenylephrine HCl
    5 mg

    APPLESAUCE 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

    2 fl. oz. (60 mL)

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    ED CHLORPED D 
    chlorpheniramine maleate and phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0096
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor APPLE (APPLESAUCE FLAVOR) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0485-0096-02 60 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/01/2011
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)