Label: KIDS-EEZE- diphenhydramine hydrochloride tablet, orally disintegrating

  • 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 April 1, 2011

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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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