Label: COLD-EEZE PLUS NATURAL MULTI-SYMPTOM RELIEF- zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf 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 January 27, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient (per lozenge)    Purpose
    Zincum Gluconicum 2XCold Remedy
    Sambucus nigra 2XFor temporary relief of flu symptoms (coughing, nasal congestion and irritated respiratory tract)
    Glycyrrhiza G. L. (Licorice Root) 3XFor 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, nasal 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
    • are under medical supervision for diabetes or have multiple sclerosis (MS), rheumatoid arthritis (RA), or an auto-immune condition

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

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

    If pregnant or breast feeding, ask a healthcare practitioner before use.

    Keep out of reach of children.

  • Directions

    • Take Cold-EEZE® Plus Natural Multi-Symptom Relief Cold & Flu Lozenges when you have cold or flu symptoms
    • Adults:
      • Dissolve entire lozenge in mouth. Do not chew. Do not swallow whole
      • Take 1 lozenge 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 6 lozenges for adults and 4 lozenges 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 Natural Multi-Symptom Relief Cold & Flu Lozenges on an empty stomach to avoid possible minor stomach upset
    • Store in a cool and dry place after opening; best if used within 6 months after opening
  • Inactive ingredients

    Corn syrup, glycine, menthol, natural colors from beet and berry extracts, natural flavors and sucrose. No artificial colors or preservatives.

  • Questions or Comments

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 12 Lozenge Package

    + SHORTENS YOUR COLD

    Cold-EEZE®
    Zinc Gluconate Glycine

    Plus Natural
    Multi-Symptom Relief

    COLD & FLU

    CLINICALLY PROVEN
    INGREDIENT

    +
    Shortens your cold, works faster®
    +
    Also helps relieve:
    ✓
    Cough
    ✓
    Congestion
    ✓
    Sore Throat

    12
    Cold Remedy
    Lozenges

    Homeopathic

    Actual size

    All Natural
    Mixed Berry Flavor

    Principal Display Panel - 12 Lozenge Package
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE   PLUS NATURAL MULTI-SYMPTOM RELIEF
    zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate2 [hp_X]
    Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower2 [hp_X]
    Glycyrrhiza Glabra Leaf (UNII: GH32M797Y9) (Glycyrrhiza Glabra Leaf - UNII:GH32M797Y9) Glycyrrhiza Glabra Leaf3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Corn Syrup (UNII: 9G5L16BK6N)  
    Glycine (UNII: TE7660XO1C)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize23mm
    FlavorBERRY (Mixed Berry) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0114-412 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/01/2016
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL(61941-0114) , ANALYSIS(61941-0114) , REPACK(61941-0114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998MANUFACTURE(61941-0114) , PACK(61941-0114) , REPACK(61941-0114)
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