Label: KIDS-EEZE- dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, orally disintegrating

  • Category: HUMAN OTC DRUG LABEL

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

    Active ingredients (in each soft chew)Purposes
    Dextromethorphan Hydrobromide 5mgCough Suppressant
    Phenylephrine Hydrochloride 2.5mgNasal Decongestant
  • Uses

    Temporarily

    • relieves cough and nasal congestion associated with a cold or hay fever
    • helps you cough less
    • controls the intensity of coughing
    • reduces the impulse to cough to help you sleep
    • relieves the cough impulses without narcotics
    • relieves stuffy nose and sinus congestion and pressure
  • Warnings

    Do not use 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 persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    • do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash, or persistent headache. These may be symptoms of a serious condition.

    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 over4 chews every 4 hours
    children 6 years to under 12 years2 chews every 4 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 acetate, croscarmellose sodium, D&C red # 27 aluminum lake, eudragit E acrylic polymer, FD&C blue #1 aluminum lake, fructose, flavors, hydroxypropylmethylcellulose, lecithin, malic acid, microcrystalline cellulose, sodium chloride, sodium lauryl sulfate, 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 SOFT CHEW PACKAGE

    NDC 61941-1003-6

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

    Cough
    &Cold

    COUGH SUPPRESSANT • DEXTROMETHORPHAN HBr 5mg

    NASAL DECONGESTANT • PHENYLEPHRINE HCl 2.5mg

    For relief of:

    +
    Coughs
    +
    Stuffy Nose
    +
    Sinus
    Congestion

    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 Soft Chew Package
  • INGREDIENTS AND APPEARANCE
    KIDS-EEZE   COUGH AND COLD
    dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-1003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    MALIC ACID (UNII: 817L1N4CKP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize17mm
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-1003-172 in 1 CASE
    1NDC:61941-1003-612 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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