Label: COLD-EEZE- zinc gluconate lozenge

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 4, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per lozenge)

    Zincum Gluconicum 2x (13.3mg)

  • Purpose

    Homeopathic Cold Remedy

  • Uses

    • to reduce the duration of the common cold
    • reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness
  • Warnings

    Ask a doctor before use if you

    • are taking monocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines

    Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

    COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • adults and children 12 years and over
    • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
    • repeat every 2 - 4 hours as needed until all symptoms subside
    • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
    • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
    • children under 12 years of age should consult a health professional prior to use
  • Other information

    • avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
    • avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids
  • STORAGE AND HANDLING

    • store in a cool dry place after opening
  • SPL UNCLASSIFIED SECTION

    • gluten-free
  • Inactive ingredients

    corn syrup, honey, glycine, lemon oil, natural green tea flavor and sucrose. No artificial colors or preservatives.

  • QUESTIONS? COMMENTS?

    CALL 1-800-505-COLD
    9am - 5pm Eastern

  • PRINCIPAL DISPLAY PANEL - 18 Lozenge Carton

    Shorten your cold!
    Get better faster!

    Quigley

    Homeopathic
    Cold-EEZE®

    Clinically proven to
    reduce the duration
    of the common cold

    Zinc
    Gluconate
    Glycine

    PHARMACIST
    RECOMMENDED•
    #1
    ACHIEVEMENT
    AWARD

    18
    Cold Remedy
    Lozenges

    Natural Green Tea
    with Honey Flavor
    with other natural flavors

    Principal Display Panel - 18 Lozenge Carton
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE  
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS) Zinc Gluconate2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Corn Syrup (UNII: 9G5L16BK6N)  
    Glycine (UNII: TE7660XO1C)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITE (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorFIG (Green Tea) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0111-124 in 1 CASE
    1NDC:61941-0111-818 in 1 PACKAGE
    2NDC:61941-0111-248 in 1 CASE
    2NDC:61941-0111-818 in 1 PACKAGE
    3NDC:61941-0111-3144 in 1 CASE
    3NDC:61941-0111-818 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2003
    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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