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Kids-EEZE (ProPhase Labs, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, ORALLY DISINTEGRATING 72 PACKAGE in 1 CASE (61941-1002-1) > 12 TABLET, ORALLY DISINTEGRATING in 1 PACKAGE (61941-1002-6) Label Information

Complete Kids-EEZE Information

  • 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 over 2 to 4 chews every 4 hours
    children 6 years to under 12 years 1 to 2 chews every 4 hours
    children under 6 years of age ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:61941-1002
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED Score no score
    Shape OVAL Size 23mm
    Flavor STRAWBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61941-1002-1 72 in 1 CASE
    1 NDC:61941-1002-6 12 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 09/01/2008
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    Name Address ID/FEI Business Operations
    ProPhase Labs, Inc. 620557298 LABEL, ANALYSIS
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE, ANALYSIS, PACK, REPACK