Label: ADVANCED HOMEOPATHIC COLD-EEZE- zincum gluconicum 2x lozenge

  • 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 September 16, 2019

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet) - Zincum Gluconicum 2x (13.3mg)

  • PURPOSE

    homeopathic cold remedy

  • INDICATIONS & USAGE

    Uses:

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

    Warnings:

    • Cold-Eeze lozenges are formulated to reduce the duration of common cold smptoms and may be insufficient treatment for influenza or allergies.

    Ask a doctor before use if you:

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

    Stop use and ask a doctor if:

    • symptoms persist beyond 7 days

    If pregnant or breastfeeding, ask a healthcare professional before use.

  • DOSAGE & ADMINISTRATION

    Directions:

    • adults and children 12 years and over
    • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
    • repeat ever 2-4 hours as needed until all symptoms subside
    • completely dissolve lozenge in mouth (do not chew)
    • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
  • OTHER SAFETY INFORMATION

    • to avoid minor stomach upset, do not dissolve lozenge on an empty stomach
    • do not eat or drink for 15 minutes after use
    • store in a cool dry place after opening
  • INACTIVE INGREDIENT

    Inactive Ingredients: corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

  • PRINCIPAL DISPLAY PANEL

    Cold-Eeze 25ct CartonCold-Eeze 25ct CartonCold-Eeze 25ct Carton

  • INGREDIENTS AND APPEARANCE
    ADVANCED HOMEOPATHIC COLD-EEZE 
    zincum gluconicum 2x lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GLYCINE (UNII: TE7660XO1C)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize23mm
    FlavorFRUITImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-122-3925 in 1 CARTON09/16/2019
    1NDC:67060-122-011 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/16/2019
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(67060-122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998manufacture(67060-122)
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!