Label: COLD EEZE- zinc gluconate 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 29, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (per lozenge)

    Zinc Gluconate 2X HPUS (2.3%) (13.3mg Zinc)

    The letters 'HPUS' indicate that the active ingredient is in the official Homeopathic Pharmacopoeia of the United States.

  • Purpose

    Cold Remedy

  • Uses

    • Reduces the duration of the common cold
    • Reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
  • Warnings

    Do not use for treatment of influenza or allergies. The product is only intended to reduce the duration of the common cold and its symptoms.

    Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on coumadin therapy. Zinc treatment may inhibit the absorption of these medicines.

    When using this product do not take on an empty stomach (to avoid possible minor stomach upset).

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

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Take one lozenge at the onset of symptoms
    • Dissolve the entire lozenge in the mouth
    • Do not chew
    • Do not swallow whole
    • Do not eat or drink for 15 minutes after use
    • Repeat every 2-4 hours until symptoms subside.

    Adults 18 years and over - do not exceed 6 lozenges per day
    Children 12 - 18 years - do not exceed 4 lozenges per day
    Children under 12 years - ask a doctor before use

  • Other Information

    • Store in a cool, dry place after opening
    • Best if used within 6 months after opening
  • Inactive Ingredients

    Corn syrup, glycine, natural flavors and sucrose

  • Questions?

    1-800-505-2653 Mon.- Fri. 8:00am-5:00pm EST

  • PRINCIPAL DISPLAY PANEL - 25 Lozenge Box

    Product# 1242

    Cold-EEZE®

    ZINC GLUCONATE HOMEOPATHIC

    • Take Cold-EEZE® at the first
      sign of a cold
    • Continue until symptoms are gone
    • Gluten Free

    SHORTENS YOUR COLD

    CLINICALLY TESTED
    to shorten colds by 42%*

    25 LOZENGES

    NATURAL
    CHERRY FLAVOR

    PRINCIPAL DISPLAY PANEL - 25 Lozenge Box
  • INGREDIENTS AND APPEARANCE
    COLD EEZE 
    zinc gluconate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1242
    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
    ColorORANGEScoreno score
    ShapeSEMI-CIRCLESize24mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1242-125 in 1 BOX; Type 0: Not a Combination Product02/02/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/02/2000
    Labeler - JHK Inc dba American Safety & First Aid (867236309)