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

  • NDC Code(s): 46017-328-44
  • Packager: Mylan Consumer Healthcare, Inc.
  • 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 January 4, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (per tablet)

    Zincum Gluconicum 1X

    Sambucus nigra 1X

    Eupatorium perfoliatum 1X

    Mentha Piperita 2X

    Myrrha 2X

    Glycyrrhiza G. L. (Licorice Root) 3X

  • Purpose

    Cold Remedy

    For temporary relief of flu symptoms (cough, nasal and chest congestion and irritated respiratory tract)

    For temporary relief of cough

    For temporary relief of Sore Throat

    For temporary relief of Irritated Throat

  • Uses

    Take one QuickMelt every 2-4 hours per Directions on other side.

    to reduce the duration of the common cold
    reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest 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 Multi-Symptom Relief Cold & Flu QuickMelts® 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 breastfeeding,

    ask a healthcare practitioner before use.

  • Keep out of reach of children.

  • Directions

    Take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® when you have cold or flu symptoms
    Adults:
    o
    Dissolve entire tablet in mouth. Do not chew. Do not swallow whole
    o
    Take 1 tablet at the onset of symptoms
    o
    Repeat every 2-4 hours as needed until all symptoms subside
    o
    Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
    o
    Recommended daily dose is 6 tablets for adults and 4 tablets 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 QuickMelts® on an empty stomach to avoid possible minor stomach upset
    Store in a cool and dry place
  • Inactive ingredients

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

    Cold-EEZE® QuickMelts®dissolve quickly in the mouth without water, releasing zinc ions in the mouth. Some scientific studies suggest that the released zinc ions inhibit the cold virus’ ability to replicate.*

    *For cold-fighting tips and more about the Cold-EEZE science, go to: www.ColdEEZE.com

    +
    Shortens Your Cold
    +
    Also Helps Relieve:
    Cough+
    Chest Congestion+
    Sore Throat+
    +
    Gluten Free
    +
    Dissolves quickly in the mouth without water
    +
    Releases zinc ions in the mouth
  • Questions or Comments

    Call 1-800-505-2653
    (M-F: 8AM-5PM ET)
    www.ColdEEZE.com

    Manufactured for:
    Mylan Consumer Healthcare, Inc.
    Morgantown, WV 26505 U.S.A.

    Mylan.com

    +THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

    CEZ:328:44:CT:R1

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

    #1 Pharmacist Recommended

    Cold-EEZE®
    ZINC GLUCONATE GLYCINE

    Plus Natural

    Multi-Symptom Relief

    Cold & Flu

    ALSO HELPS RELIEVE:

    Cough+
    Chest Congestion+
    Sore Throat+

    24
    QuickMelts®
    HOMEOPATHIC

    NATURAL FLAVOR

    Honey Lemon

    Cold-EEZE Honey Lemon QuickMelt Carton Label
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE  NATURAL MULTI-SYMPTOM RELIEF
    zinc gluconate, sambucus nigra flower, eupatorium perfoliatum flowering top, mentha piperita, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-328
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
    Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower1 [hp_X]
    Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top1 [hp_X]
    Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9) Mentha Piperita2 [hp_X]
    Myrrh (UNII: JC71GJ1F3L) (Myrrh - UNII:JC71GJ1F3L) Myrrh2 [hp_X]
    Glycyrrhiza Glabra Leaf (UNII: GH32M797Y9) (Glycyrrhiza Glabra Leaf - UNII:GH32M797Y9) Glycyrrhiza Glabra Leaf3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Glycine (UNII: TE7660XO1C)  
    .Beta.-Carotene (UNII: 01YAE03M7J)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Honey (UNII: Y9H1V576FH)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (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)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOCTAGON (8 sided)Size15mm
    FlavorLEMON (honey lemon) Imprint Code ZM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46017-328-444 in 1 BOX02/14/201910/31/2022
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/14/201910/31/2022
    Labeler - Mylan Consumer Healthcare, Inc. (831410522)