Label: COLD-EEZE COLD REMEDY ULTRAMELT CHEWS- zinc gluconate tablet, chewable

  • 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 January 1, 2023

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  • Drug Facts

  • Active ingredient

    Active ingredient (per tablet )
    Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc)

    † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

  • Purposes

    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. This product is intended only 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 (warfarin) 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 more than 7 days

    If pregnant or breastfeeding, ask a healthcare 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 chewable tablet at the onset of symptoms • chew slowly and dissolve completely in mouth before swallowing
    • 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 overdo not exceed 6 chewable tablets per day
    Children 12 to under 18 yearsdo not exceed 4 chewable tablets per day
    Children under 12 yearsask a doctor before use

  • Other information

    • store in a cool, dry place after opening
    • best if used within 6 months after opening
  • Inactive ingredients

    acesulfame potassium, erythritol, FD&C red no. 40 aluminum lake, FD&C yellow No. 5 (tartrazine) aluminum lake, glycine, hydroxypropyl cellulose, isomalt, magnesium stearate, natural flavors, sucarlose, xylitol

  • Questions?

    call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Cold-EEZE ®

    COLD REMEDY

    ZINC GLUCONATE HOMEOPATHIC

    SHORTENS YOUR COLD ®

    UltraMELT ® Chews

    GREAT Tasting

    QUICK DISSOLVING Tablets

    NATURAL ORANGE FLAVOR

    24 Chewable Tablets

    ©2022 Vespyr Brands ®, Inc.

    Cold-EEZE ® and ULTRAMELT ® are registered trademarks of Vespyr Brands ®, Inc.

    Distributed by Vespyr Brands ®, Inc.

    East Windsor, NJ 08520 USA

    This product has not been evaluated by the FDA

    Made in Denmark

    www.coldeeze.com

    label

  • INGREDIENTS AND APPEARANCE
    COLD-EEZE COLD REMEDY  ULTRAMELT CHEWS
    zinc gluconate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71179-350
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE13.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCINE (UNII: TE7660XO1C)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ISOMALT (UNII: S870P55O2W)  
    FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)  
    ERYTHRITOL (UNII: RA96B954X6)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Product Characteristics
    Colorwhite (2nd side orange-pink) Scorescore with uneven pieces
    ShapeROUNDSize11mm
    FlavorORANGEImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71179-350-242 in 1 BOX07/01/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2021
    Labeler - Vespyr Brands Inc (118094893)
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