Label: COLD-EEZE - zinc gluconate lozenge

  • NDC Code(s): 61941-0111-1, 61941-0111-2, 61941-0111-3, 61941-0111-8
  • Packager: ProPhase Labs, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 04/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (per lozenge)

    Zincum Gluconicum 2x (13.3mg)

    Close
  • Purpose

    Homeopathic Cold Remedy

    Close
  • 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
    Close
  • 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.

    Close
  • 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
    Close
  • 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
    Close
  • STORAGE AND HANDLING

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

    • gluten-free
    Close
  • Inactive ingredients

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

    Close
  • QUESTIONS? COMMENTS?

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

    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE  
    zinc gluconate lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0111
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS) Zinc Gluconate 2 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    Corn Syrup (UNII: 9G5L16BK6N)  
    Glycine (UNII: TE7660XO1C)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    Color WHITE (Semi-Translucent) Score no score
    Shape OVAL Size 23mm
    Flavor FIG (Green Tea) Imprint Code P
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61941-0111-1 24 in 1 CASE
    1 NDC:61941-0111-8 18 in 1 PACKAGE
    2 NDC:61941-0111-2 48 in 1 CASE
    2 NDC:61941-0111-8 18 in 1 PACKAGE
    3 NDC:61941-0111-3 144 in 1 CASE
    3 NDC:61941-0111-8 18 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 02/01/2003
    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
    Close