KIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]

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KIDS-EEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]
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NDC 61941-1005-1, 61941-1005-6
Set ID cf4f599c-f3b2-4e07-8157-1486094ee52b
Category HUMAN OTC DRUG LABEL
Packager ProPhase Labs, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each soft chew)

    Diphenhydramine Hydrochloride 12.5mg

  • Purpose

    Antihistamine

  • Uses

    For the temporary relief of

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on the skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

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

    When using this product

    • marked drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Chew and swallow as directed below

    • Do not take more than 6 doses in 24 hours
    adults and children 12 years and over2 to 4 chews every 4 to 6 hours
    children 6 years to under 12 years1 to 2 chews every 4 to 6 hours
    children under 6 years of ageask a doctor
  • Other information

    • each soft chew contains 6 mg sodium
    • tamper evident: do not use if inner blister pack is torn or open
    • store at controlled room temperature 15-30°C (59-86°F)
  • Inactive ingredients

    ammonium glycyrrhizinate, cellulose, croscarmellose sodium, D&C red #27 lake, ethylcellulose, FD&C blue #1 lake, fructose, flavors, hydroxypropylcellulose, lecithin, malic acid, microcrystalline cellulose, sodium chloride, sucralose, sugar, vegetable oil, xylitol

  • QUESTIONS

    To report serious side effects associated with the use of this product call 1-800-505-COLD (2653)

  • PRINCIPAL DISPLAY PANEL - 12.5 mg Package

    NDC 61941-1005-6

    Kids-EEZE®
    From The Makers Of
    Cold-EEZE    ®

    Allergy

    ANTIHISTAMINE • DIPHENHYDRAMINE HCl 12.5mg
    Due to hay fever or upper respiratory allergies

    For relief of:

    +
    Runny Nose
    +
    Sneezing
    +
    Itchy Watery
    Eyes
    +
    Itchy
    Throat

    Soft Chew

    Great Tasting Grape

    ARTIFICIALLY FLAVORED
    12 SOFT CHEWS

    TAMPER EVIDENT: Do Not Use If Inner Seal Is Torn Or Open

    Principal Display Panel - 12.5 mg Package
  • INGREDIENTS AND APPEARANCE
    KIDS-EEZE   ALLERGY
    diphenhydramine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-1005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    MALIC ACID (UNII: 817L1N4CKP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize17mm
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-1005-172 in 1 CASE
    1NDC:61941-1005-612 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/2010
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL, ANALYSIS
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998MANUFACTURE, ANALYSIS, PACK, REPACK
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