Label: KIDS-EEZE- guaifenesin 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)

    Guaifenesin, USP 100 mg

  • Purpose

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

  • Warnings

    Ask a doctor before use if you have

    • a sodium-restricted diet
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs 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 over2 to 4 chews every 4 hours
    children 6 years to under 12 years1 to 2 chews every 4 hours
    children under 6 years of ageask a doctor
  • Other information

    • each soft chew contains 17 mg sodium
    • tamper evident: do not use if inner blister pack is torn or open
    • store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    croscarmelose sodium, ethylcellulose, FD&C red #40 lake, ethylene glycol & vinyl alcohol graft copolymer, malic acid, methacrylic copolymer, monoammonium glycyrrhizinate, non fat dry milk, octaglycerol monooleate emulsifier, vegetable oil, polysorbate 80, salt, silicon dioxide, sodium starch glycolate, soy lecithin, strawberry flavors, sucralose, sugar, vanilla flavor

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Carton

    NDC 61941-1002-6

    Kids-EEZE®

    From The Makers Of
    Cold-EEZE®

    Chest
    Relief

    EXPECTORANT • GUAIFENESIN 100 mg

    +
    Relieves Chest
    Congestion
    +
    Thins &
    Loosens
    Mucus

    Soft Chew

    Great Tasting
    Strawberry

    ARTIFICIALLY FLAVORED
    12 SOFT CHEWS

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

    PRINCIPAL DISPLAY PANEL - 100 mg Tablet Carton
  • INGREDIENTS AND APPEARANCE
    KIDS-EEZE   CHEST RELIEF
    guaifenesin tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-1002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)  
    ETHYLENE GLYCOL (UNII: FC72KVT52F)  
    MALIC ACID (UNII: 817L1N4CKP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize23mm
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-1002-172 in 1 CASE
    1NDC:61941-1002-612 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/2008
    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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