Label: COLD-EEZE - zinc gluconate lozenge 

  • Label RSS
  • 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (per lozenge)

    Zincum Gluconicum 2x (13.3mg)

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  • Purpose

    Homeopathic Cold Remedy

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  • 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
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  • 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.

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  • 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
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  • 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
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  • STORAGE AND HANDLING

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

    • gluten-free
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  • Inactive ingredients

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

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  • QUESTIONS? COMMENTS?

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    COLD-EEZE  
    zinc gluconate lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61941-0111
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Gluconate (Zinc) Zinc Gluconate 2 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    Corn Syrup  
    Glycine  
    Sucrose  
    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
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