ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]

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ED CHLORPED JR (CHLORPHENIRAMINE MALEATE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]
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NDC 0485-0098-04, 0485-0098-16
Set ID 4a5e5968-1930-465a-9b8c-45ed936a0e11
Category HUMAN OTC DRUG LABEL
Packager EDWARDS PHARMACEUTICALS, INC.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each 5 mL teaspoonful)

    Chlorpheniramine Maleate 2 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies:

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

    Do not exceed recommended dosage.

    Do not take this product, unless directed by a doctor, if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • 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

    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:2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children under 6 years of age:

    Consult a doctor
    .
  • Other information

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

  • Inactive ingredients

    Cherry Flavor, Citric Acid, FD&C Red # 40, 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

    ED Chlorped Jr.

    E

    NDC 0485-0098-16

    ED Chlorped Jr.

    ANTIHISTAMINE

    FOR PROFESSIONAL USE ONLY

    Sugar Free • Alcohol Free

    Each teaspoonful (5 mL)

    for oral administration contains:

    Chlorpheniramine Maleate 2 mg

    Cherry 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)

    label

  • INGREDIENTS AND APPEARANCE
    ED CHLORPED JR 
    chlorpheniramine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0098
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0098-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/04/2011
    2NDC:0485-0098-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/04/201109/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/04/2011
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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