Label: COLD-EEZE NATURAL ALLERGY RELIEF- onion, eupatorium perfoliatum flowering top, buckwheat, symplocarpus foetidus root, sambucus nigra flower, tussilago farfara leaf, urtica dioica, and zinc gluconate tablet, delayed release

  • 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 28, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (per caplet)

    Allium Cepa L 2X
    Eupatorium perfoliatum 1X
    Polygonum fagopyrum L. 2X
    Pothos Foetidus 2X
    Sambucus nigra 1X
    Tussilago petasites L.1X
    Urtuca dioica 1X
    Zincum Gluconicum 2X

  • Purpose

    For temporary relief of symptoms associated with allergies

  • Uses

    For temporary relief of symptoms associated with allergies: Breathing difficulties, headache, congestion, itchy eyes, runny nose, stuffy nose and bronchial spasms

  • Warnings

    Ask a doctor before use if you

    • Are on anticoagulant therapy, barbiturates, or are under medical supervision for diabetes and are taking diabetes medication, as sambucus nigra (Elder Flower) can decrease blood sugar levels

    Stop use and ask your healthcare practitioner if you have noticed any allergic reaction or rashes or if symptoms persist beyond 5 days.

    Cold-EEZE® Natural Allergy Relief is formulated to help you with temporary relief of symptoms associated with indoor/outdoor and seasonal allergies

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

    Keep out of reach of children.

  • Directions

    • Take Cold-EEZE® Natural Allergy Symptom Relief when you have allergy symptoms
    • For ages 12 years and older:
      • Take 1 caplet with water
      • Repeat every 8-12 hours as needed until all symptoms subside
      • Do Not Take more than 3 caplets per day
    • Recommended daily dose is 2 caplets per day
    • For individuals under the age of 12, consult a healthcare practitioner before use
  • Other information

    • Do not crush or divide the Cold-EEZE® Natural Allergy Symptom Relief caplets
    • Store in a dark, cool and dry place
  • Inactive ingredients

    Carbopol, dibasic calcium phosphate, magnesium stearate, methocel, microcrystalline cellulose, silicon dioxide, stearic acid.

  • Questions or Comments

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Box

    NEW

    From the makers of
    Cold-EEZE®

    NATURAL
    ALLERGY
    RELIEF™

    Up to 12 Hours Extended-Release

    For Relief of:

    ☑
    Congestion
    ☑
    Itchy Eyes
    ☑
    Runny Nose
    & Stuffy Nose

    Non
    Drowsy

    20
    Coated
    Caplets

    Homeopathic

    Actual size

    For Indoor
    & Outdoor
    Allergies

    Principal Display Panel - 20 Caplet Blister Pack Box
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE   NATURAL ALLERGY RELIEF
    onion, eupatorium perfoliatum flowering top, buckwheat, symplocarpus foetidus root, sambucus nigra flower, tussilago farfara leaf, urtica dioica, and zinc gluconate tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0229
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion2 [hp_X]
    Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top1 [hp_X]
    Buckwheat (UNII: N0Y68724R3) (Buckwheat - UNII:N0Y68724R3) Buckwheat2 [hp_X]
    Symplocarpus Foetidus Root (UNII: R88254608W) (Symplocarpus Foetidus Root - UNII:R88254608W) Symplocarpus Foetidus Root2 [hp_X]
    Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower1 [hp_X]
    Tussilago Farfara Leaf (UNII: G2GH7V846Z) (Tussilago Farfara Leaf - UNII:G2GH7V846Z) Tussilago Farfara Leaf1 [hp_X]
    Urtica Dioica (UNII: 710FLW4U46) (Urtica Dioica - UNII:710FLW4U46) Urtica Dioica1 [hp_X]
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Calcium Phosphate, Dibasic, Dihydrate (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Methylcellulose (25 MPA.S) (UNII: BI55GG2WLI)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorGRAYScoreno score
    ShapeOVALSize2mm
    FlavorImprint Code ZA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0229-42 in 1 BOX
    1NDC:61941-0229-110 in 1 BLISTER PACK; 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(61941-0229) , ANALYSIS(61941-0229) , REPACK(61941-0229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998MANUFACTURE(61941-0229) , PACK(61941-0229) , REPACK(61941-0229)
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