Label: COLD-EEZE COLD REMEDY- zinc gluconate, rosa canina, echinacea purpurea chewable gel

  • 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 14, 2023

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

  • Drug Facts

  • Active ingredients

    Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes
    Zinc Gluconate 1X HPUS (8.8%) (13.2 mg zinc).................... Cold Remedy
    Rosa Caina (Rose Hips) 2X HPUS (1.0%) ............................ Promotes immune support*
    Echinacea Purpurea 1X HPUS (0.02%)................................... Promotes immune support*
    The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

  • Purposes
  • Uses

    • to reduce the duration of the common cold
    • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
    • supports immune system health*
  • Warnings

    Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and provide relief of cold and flu symptoms.

    Ask a doctor before use if you have
    • diabetes

    • multiple sclerosis (MS)

    • rheumatoid arthritis (RA) or other auto-immune condition

    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 gel at 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 gels per day
    Children 12 to under 18 yearsdo not exceed 4 chewable gels per day
    Children under 12 yearsask a doctor before use

  • Other information

    • each chewable gel contains: sodium 10 mg
    • store at room temperature in a cool, dry place
    • do not expose to excessive heat for long periods of time
  • Inactive ingredients

    citric acid, corn syrup, flavors, glycine, malic acid, pectin, sambucus nigra (european elder), sucrose, sugar, tricalcium phosphate, trisodium citrate dihydrate, water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Cold-EEZE ®

    COLD REMEDY

    HOMEOPATHIC

    SHORTENS YOUR COLD

    Plus DEFENSE*

    PROMOTES Immune Health*

    NATURAL FLAVOR CITRUS WITH ELDERBERRY

    25 Chewable Gels

    ©2022 Vespyr Brands ®, Inc.

    Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.

    Distributed by Vespyr Brands ®, Inc.

    East Windsor, NJ 08520

    This product has not been evaluated by the FDA

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    label

    drug facts

  • INGREDIENTS AND APPEARANCE
    COLD-EEZE COLD REMEDY 
    zinc gluconate, rosa canina, echinacea purpurea chewable gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71179-341
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3) (ROSA CANINA FRUIT - UNII:3TNW8D08V3) ROSA CANINA FRUIT2 mg
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 mg
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE13.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUGARCANE (UNII: 81H2R5AOH3)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCINE (UNII: TE7660XO1C)  
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    MALIC ACID (UNII: 817L1N4CKP)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    WATER (UNII: 059QF0KO0R)  
    PECTIN (UNII: 89NA02M4RX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorpurpleScore    
    ShapeROUNDSize23mm
    FlavorCITRUS (with Elderberry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71179-341-2525 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/31/2023
    Labeler - Vespyr Brands Inc (118094893)