Label: COLD-EEZE PLUS NIGHTTIME MULTI-SYMPTOM RELIEF- zinc gluconate, eupatorium perfoliatum flowering top, sambucus nigra flower, valerian, chamomile, mentha piperita, 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 July 25, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (per tablet)Purpose
    Zincum Gluconicum 1XCold Remedy
    Eupatorium perfoliatum 1XFor temporary relief of flu symptoms
    Sambucus nigra 1X(cough, nasal and chest congestion and irritated respiratory tract)
    Valeriana Officinalis 1XSleep Disorder Remedy
    Chamomile (Matricaria recutita) 2XRelaxation and Calming
    Mentha Piperita 2XFor temporary relief of cough
    Myrrha 2XFor temporay relief of Sore Throat
    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 and chest congestion, post nasal drip and/or hoarseness
    • helps for temporary relief of Sore Throat
    • helps to relax and sleep easier to get rested
  • Warnings

    Ask a doctor before use if you

    • are taking fluvoxamine (Luvox), minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines
    • are under medical supervision and/or are taking tranquilizers, sedatives or anti-seizure medicines
    • are under medical supervision for diabetes or have multiple sclerosis (MS), rheumatoid arthritis (RA) or an auto-immune condition

    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.

    Do not use

    • if taking loperamide
    • while operating a motor vehicle or machinery or consuming alcohol

    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 Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® is a combination product formulated to help you to sleep easier, 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.

    If pregnant or breastfeeding, ask a healthcare practitioner 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 Cold-EEZE® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® at night when you have cold or flu symptoms
    • Adults:
      • Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
      • Take 1 tablet 1 hour before bedtime
      • Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
    • Recommended dose is 1 tablet for adults
    • Allow 6-8 hours for sleep after taking tablet
    • For individuals under the age of 18, consult a healthcare practitioner before use
  • Other information

    • Do not take Cold-EEZE® Plus Nighttime 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

    crospovidone, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural color from carrot and hibiscus concentrates, natural flavors, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose

  • QUESTIONS

    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 - 18 Tablet Blister Pack Carton

    Relax & Sleep!+
    #1 Pharmacist Recommended

    Cold-EEZE®

    ZINC GLUCONATE GLYCINE

    SHORTENS YOUR COLD,
    WORKS FASTER®+

    Plus Nighttime
    Multi-Symptom Relief
    Cold & Flu

    ALSO HELPS RELIEVE:

    ☑
    Cough+
    ☑
    Sore Throat+
    ☑
    Chest Congestion+

    Fall asleep faster,
    naturally+

    CLINICALLY PROVEN
    INGREDIENT

    18
    QuickMelts®
    HOMEOPATHIC
    (actual
    size)

    NATURAL FLAVOR
    Mixed Berry

    PRINCIPAL DISPLAY PANEL - 18 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE   PLUS NIGHTTIME MULTI-SYMPTOM RELIEF
    zinc gluconate, eupatorium perfoliatum flowering top, sambucus nigra flower, valerian, chamomile, mentha piperita, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0231
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
    Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top1 [hp_X]
    Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower1 [hp_X]
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian1 [hp_X]
    Chamomile (UNII: FGL3685T2X) (Chamomile - UNII:FGL3685T2X) Chamomile2 [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
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    GLYCINE (UNII: TE7660XO1C)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    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)  
    Product Characteristics
    ColorGRAYScoreno score
    ShapeOCTAGON (8 SIDED)Size15mm
    FlavorBERRY (Mixed Berry) Imprint Code PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0231-83 in 1 CARTON08/15/2016
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/15/2016
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL(61941-0231)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998PACK(61941-0231) , ANALYSIS(61941-0231) , REPACK(61941-0231) , MANUFACTURE(61941-0231)
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