Label: COLD-EEZE PLUS IMMUNE SUPPORT- zinc gluconate, rosa canina leaf, and echinacea purpurea tablet, orally disintegrating

  • 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 August 22, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (per tablet)Purpose
    Zincum Gluconicum 1XCold Remedy
    Rosa Canina L. (Rose Hip) 1XPromotes Immune support
    Echinacea Purpurea Extract 2XPromotes Immune support
  • 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

    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 a skin condition called pemphigus vulgaris 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 Immune Support QuickMelts® is a combination product formulated to help you to reduce the duration of the common cold and its symptoms and promote immune system health. 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 Immune Support QuickMelts® when you have cold symptoms.
    • Adults:
      • Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
      • Take 1 tablet 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 tablets for adults.
    • For individuals under the age of 18, consult a healthcare practitioner before use.
  • Other information

    • Do not take on an empty stomach to avoid possible minor stomach upset.
    • Echinacea might cause a slight tingling sensation on the tongue.
    • Store in a cool and dry place.
  • Other ingredients

    beta carotene, crospovidone, glycine, magnesium stearate, malic acid, mannitol, microcrystalline cellulose, natural menthol flavor, natural orange flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate sodium starch glycolate, stevia, sucralose, talc.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Package

    NEW QuickMelts®

    GREAT
    TASTE

    Cold-EEZE®

    Zinc Gluconate Glycine

    COLD REMEDY

    Plus Natural
    Immune Support

    ✔
    Shortens Your Cold, Works Faster
    ✔
    Promotes Immune Health,
    Antioxidant Support
    • Rose Hips: Rich in Natural Vitamin C
    • Echinacea

    24 QuickMelts®
    Homeopathic

    Natural
    Orange Flavor

    Principal Display Panel - 24 Tablet Package
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE   PLUS IMMUNE SUPPORT
    zinc gluconate, rosa canina leaf, and echinacea purpurea tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0223
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
    ROSA CANINA LEAF (UNII: J3N2Z889QP) (ROSA CANINA LEAF - UNII:J3N2Z889QP) ROSA CANINA LEAF1 [hp_X]
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    GLYCINE (UNII: TE7660XO1C)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MENTHOL (UNII: L7T10EIP3A)  
    ORANGE (UNII: 5EVU04N5QU)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOCTAGON (8 SIDED)Size15mm
    FlavorORANGE (NATURAL) Imprint Code ZC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0223-44 in 1 PACKAGE
    1NDC:61941-0223-16 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC09/01/2013
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL(61941-0223) , ANALYSIS(61941-0223) , REPACK(61941-0223)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998PACK(61941-0223) , REPACK(61941-0223)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blispak, Inc.194902235MANUFACTURE(61941-0223) , ANALYSIS(61941-0223) , PACK(61941-0223)
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