Label: COLD-EEZE- zinc gluconate lozenge

  • Contains inactivated NDC Code(s)
    NDC Code(s):     61941-0081-1, 61941-0081-2, 61941-0081-3, 61941-0081-8, view more
    61941-0082-4, 61941-0091-1, 61941-0091-2, 61941-0091-3, 61941-0091-8, 61941-0092-4, 61941-0101-1, 61941-0101-2, 61941-0101-3, 61941-0101-8, 61941-0102-4
  • Packager: ProPhase Labs, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 March 30, 2011

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per lozenge)

    Zincum Gluconicum 2x (13.3mg)

  • Purpose

    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 minocycline, 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.

    Diabetic Warning: sugar replacements may affect blood sugar levels.

    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
    • store in a cool dry place after opening
    • gluten-free
    • product may produce a laxative effect
  • Inactive ingredients

    Acesulfame-K, glycine, Isomalt, natural flavors. No artificial colors or preservatives.

  • Questions or Comments:

    Call 1-800-505-COLD
    (9AM-5PM EST)

  • PRINCIPAL DISPLAY PANEL - 18 Lozenge Wild Cherry Carton

    GREAT
    NEW TASTE

    Cold-EEZE®
    Zinc Gluconate Glycine

    COLD REMEDY

    SUGAR FREE

    OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    +
    Clinically proven to reduce the
    duration of the common cold ®
    +
    #1 Pharmacist Recommended
    +
    Shortens your cold, works fast

    18
    Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Wild Cherry Flavor
    with other natural flavors

    PRINCIPAL DISPLAY PANEL - 18 Lozenge Wild Cherry Carton
  • PRINCIPAL DISPLAY PANEL - 24 Lozenge Wild Cherry Carton

    GREAT
    NEW TASTE

    Cold-EEZE®
    Zinc Gluconate Glycine

    33%
    MORE
    FREE

    COLD REMEDY

    SUGAR FREE

    OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    +
    Clinically proven to reduce the
    duration of the common cold ®
    +
    #1 Pharmacist Recommended
    +
    Shortens your cold, works fast

    24
    Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Wild Cherry Flavor
    with other natural flavors

    PRINCIPAL DISPLAY PANEL - 24 Lozenge Wild Cherry Carton
  • PRINCIPAL DISPLAY PANEL - 18 Lozenge Honey Lemon Carton

    GREAT
    NEW TASTE

    Cold-EEZE®
    Zinc Gluconate Glycine

    COLD REMEDY

    SUGAR FREE

    OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    +
    Clinically proven to reduce the
    duration of the common cold ®
    +
    #1 Pharmacist Recommended
    +
    Shortens your cold, works fast

    18
    Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Honey Lemon Flavor
    with other natural flavors

    PRINCIPAL DISPLAY PANEL - 18 Lozenge Honey Lemon Carton
  • PRINCIPAL DISPLAY PANEL - 24 Lozenge Honey Lemon Carton

    GREAT
    NEW TASTE

    Cold-EEZE®
    Zinc Gluconate Glycine

    33%
    MORE
    FREE

    COLD REMEDY

    SUGAR FREE

    OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    +
    Clinically proven to reduce the
    duration of the common cold ®
    +
    #1 Pharmacist Recommended
    +
    Shortens your cold, works fast

    24
    Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Honey Lemon Flavor
    with other natural flavors

    PRINCIPAL DISPLAY PANEL - 24 Lozenge Honey Lemon Carton
  • PRINCIPAL DISPLAY PANEL - 18 Lozenge Pomegranate Carton

    GREAT
    NEW TASTE

    Cold-EEZE®
    Zinc Gluconate Glycine

    COLD REMEDY

    SUGAR FREE

    OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    +
    Clinically proven to reduce the
    duration of the common cold ®
    +
    #1 Pharmacist Recommended
    +
    Shortens your cold, works fast

    18
    Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Pomegranate Flavor
    with other natural flavors

    PRINCIPAL DISPLAY PANEL - 18 Lozenge Pomegranate Carton
  • PRINCIPAL DISPLAY PANEL - 24 Lozenge Pomegranate Carton

    GREAT
    NEW TASTE

    Cold-EEZE®
    Zinc Gluconate Glycine

    33%
    MORE
    FREE

    COLD REMEDY

    SUGAR FREE

    OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    +
    Clinically proven to reduce the
    duration of the common cold ®
    +
    #1 Pharmacist Recommended
    +
    Shortens your cold, works fast

    24
    Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Pomegranate Flavor
    with other natural flavors

    PRINCIPAL DISPLAY PANEL - 24 Lozenge Pomegranate Carton
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0081
    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
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Glycine (UNII: TE7660XO1C)  
    Isomalt (UNII: S870P55O2W)  
    Product Characteristics
    ColorWHITE (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorCHERRY (Sugar Free Wild Cherry) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0081-124 in 1 CASE
    1NDC:61941-0081-818 in 1 PACKAGE
    2NDC:61941-0081-248 in 1 CASE
    2NDC:61941-0081-818 in 1 PACKAGE
    3NDC:61941-0081-3144 in 1 CASE
    3NDC:61941-0081-818 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2005
    COLD-EEZE 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0082
    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
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Glycine (UNII: TE7660XO1C)  
    Isomalt (UNII: S870P55O2W)  
    Product Characteristics
    ColorWHITE (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorCHERRY (Sugar Free Wild Cherry) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0082-424 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2005
    COLD-EEZE 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0091
    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
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Glycine (UNII: TE7660XO1C)  
    Isomalt (UNII: S870P55O2W)  
    Product Characteristics
    ColorWHITE (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorHONEY (Sugar Free Honey Lemon) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0091-124 in 1 CASE
    1NDC:61941-0091-818 in 1 PACKAGE
    2NDC:61941-0091-248 in 1 CASE
    2NDC:61941-0091-818 in 1 PACKAGE
    3NDC:61941-0091-3144 in 1 CASE
    3NDC:61941-0091-818 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2005
    COLD-EEZE 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0092
    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
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Glycine (UNII: TE7660XO1C)  
    Isomalt (UNII: S870P55O2W)  
    Product Characteristics
    ColorWHITE (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorHONEY (Sugar Free Honey Lemon) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0092-424 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2005
    COLD-EEZE 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0101
    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
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Glycine (UNII: TE7660XO1C)  
    Isomalt (UNII: S870P55O2W)  
    Product Characteristics
    ColorWHITE (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorPOMEGRANATE (Sugar Free Pomegranate) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0101-124 in 1 CASE
    1NDC:61941-0101-818 in 1 PACKAGE
    2NDC:61941-0101-248 in 1 CASE
    2NDC:61941-0101-818 in 1 PACKAGE
    3NDC:61941-0101-3144 in 1 CASE
    3NDC:61941-0101-818 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2005
    COLD-EEZE 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0102
    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
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Glycine (UNII: TE7660XO1C)  
    Isomalt (UNII: S870P55O2W)  
    Product Characteristics
    ColorWHITE (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorPOMEGRANATE (Sugar Free Pomegranate) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0102-424 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2005
    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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!