KIDS-EEZE (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]

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  • KIDS-EEZE (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]

KIDS-EEZE (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]
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NDC 61941-1003-1, 61941-1003-6
Set ID e30a7367-a865-4730-9204-34a872a54c18
Category HUMAN OTC DRUG LABEL
Packager ProPhase Labs, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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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