Label: COLD-EEZE GUMMIES PLUS MULTI-SYMPTOM RELIEF COLD AND FLU- zinc gluconate, mentha piperita, eupatorium perfoliatum flowering top, sambucus nigra flower, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating

  • Category: HUMAN OTC DRUG LABEL

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 October 11, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (2 gummies)Purpose
    Zincum Gluconicum 1XCold Remedy
    Mentha piperita 1XFor temporary relief of cough
    Sambucus nigra 2XFor temporary relief of flu symptoms
    Eupatorium perfoliatum 2X(cough, congestion and irritated respiratory tract)
    Myrrha 2XFor temporary relief of Sore Throat
    Glycyrrhiza G. L. (Licorice Root) 2XFor temporary relief of Irritated Throat
  • Uses

    • to reduce the duration of the common cold
    • reduces the severity of cold and flu symptoms: cough, sore throat, congestion, post nasal drip and/or hoarseness
    • helps for temporary relief of Sore Throat
  • Warnings

    Ask a doctor before use if you

    • are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines

    Stop use and ask your healthcare practitioner if symptoms persist for more than 7 days or are accompanied by fever, rash or persistent headache

    Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu gummies is a combination product formulated to help you to reduce the duration of the common cold and to help for temporary relief of Cold and Flu symptoms. It is insufficient treatment for Influenza or Allergies.

    Sore Throat Warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

    If pregnant or breastfeeding, ask a healthcare practitioner before use

    Keep out of reach of children

  • Directions

    • Take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu gummies when you have cold or flu symptoms
    • Adults:
      • Dissolve 2 gummies in mouth. Do not swallow whole. For best results, dissolve in your mouth.
      • Take 2 gummies at the onset of symptoms
      • Repeat every 2-4 hours as needed until all symptoms subside
      • Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
      • Recommended daily dose is 12 gummies for adults and 8 gummies for ages 12-17 years
    • For children under 12 years of age, consult a healthcare practitioner before use
  • Other information

    • Do not take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu gummies on an empty stomach to avoid possible minor stomach upset
    • Store in a cool and dry place
  • Inactive ingredients

    Citric acid, corn syrup, gelatin, glycine, maltodextrin, natural flavors and colors from fruits and vegetables, pectin and sugar (from beets)

  • Questions or Comments

    Call 1-800-505-2653
    (M-F: 9AM-5PM EST)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    ProPhase Labs, Inc.
    P.O. Box 1349, Doylestown
    PA 18901

  • PRINCIPAL DISPLAY PANEL - 36 gummy Bottle Label

    NEW
    for
    Adults &
    Kids 12
    & up

    Cold-EEZE®
    ZINC GLUCONATE GLYCINE

    gummies

    SHORTENS YOUR COLD,
    WORKS FASTER®+

    Plus
    Multi-Symptom
    Relief
    Cold & Flu

    36
    gummies
    HOMEOPATHIC

    Also Helps Relieve:

    ✓
    Cough+
    ✓
    Congestion+
    ✓
    Sore Throat+

    NATURAL FLAVOR
    Mixed Fruit

    PRINCIPAL DISPLAY PANEL - 36 gummy Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE   GUMMIES PLUS MULTI-SYMPTOM RELIEF COLD AND FLU
    zinc gluconate, mentha piperita, eupatorium perfoliatum flowering top, sambucus nigra flower, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
    Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9) Mentha Piperita1 [hp_X]
    eupatorium perfoliatum flowering top (UNII: 1W0775VX6E) (eupatorium perfoliatum flowering top - UNII:1W0775VX6E) eupatorium perfoliatum flowering top2 [hp_X]
    sambucus nigra flower (UNII: 07V4DX094T) (sambucus nigra flower - UNII:07V4DX094T) sambucus nigra flower2 [hp_X]
    MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH2 [hp_X]
    GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9) (GLYCYRRHIZA GLABRA LEAF - UNII:GH32M797Y9) GLYCYRRHIZA GLABRA LEAF2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    Gelatin, Unspecified (UNII: 2G86QN327L)  
    Glycine (UNII: TE7660XO1C)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Pectin (UNII: 89NA02M4RX)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize15mm
    FlavorBERRY (Mixed Berry) Imprint Code Smiley;Face
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0234-036 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC10/01/2016
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL(61941-0234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998PACK(61941-0234) , ANALYSIS(61941-0234) , REPACK(61941-0234) , MANUFACTURE(61941-0234)
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

More Info on this Drug

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