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

  • NDC Code(s): 46017-322-96
  • Packager: Mylan Consumer Healthcare, Inc.
  • 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 December 18, 2017

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  • Active Ingredient (per lozenge)

    Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc)
    Sambucus Nigra 2X HPUS† (1.0%)
    Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)

    †The letters ‘HPUS’ indicates that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

  • Purpose

    Cold Remedy
    relieves cough, nasal congestion and irritated respiratory tract*
    relieves irritated throat*

  • Uses

    •
    reduces the duration of the common cold
    •
    reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
    •
    temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with colds and flu*
  • Warnings

    Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and provide relief of cold and flu symptoms.

  • Ask a doctor before use if you have

    •
    diabetes
    •
    multiple sclerosis (MS)
    •
    rheumatoid arthritis (RA) or other auto-immune condition
  • Ask a doctor or pharmacist before use if you are

    taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

  • When using this product

    do not take on an empty stomach (to avoid possible minor stomach upset).

  • Stop use and ask your doctor if

    symptoms persist beyond 7 days

  • If pregnant or breastfeeding,

    ask a healthcare practitioner before use.

  • Keep out of reach of children.

  • Directions

    •
    take one lozenge at the onset of symptoms
    •
    do not swallow whole
    •
    dissolve entire lozenge in mouth
    •
    do not eat or drink for 15 minutes after use
    •
    do not chew
    •
    repeat every 2-4 hours until symptoms subside

    Adults 18 years and over

    do not exceed 6 lozenges per day

    Children 12 to under 18 years

    do not exceed 4 lozenges per day

    Children under 12 years

    ask a doctor before use
  • Other information

    •
    store in a cool, dry place after opening
    •
    best if used within 6 months after opening
  • Inactive ingredients

    Corn syrup, glycine, natural colors, natural flavors and sucrose

  • Questions or Comments:

    Call 1-800-505-2653 (Monday-Friday: 8am-5pm EST)

  • SPL UNCLASSIFIED SECTION

    This product has not been evaluated by the FDA.

     

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    No artificial colors or preservatives

    ‡Based on the Cold-EEZE brand unit sales of cold shortening, homeopathic zinc lozenges.

    ©2019 Mylan Inc.

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

    This product has no expiration date

  • Principal Display Panel – Mixed Berry

    NDC 46017-322-96

    Cold-EEZE
    HOMEOPATHIC

    SHORTENS YOUR COLD

    Plus Natural
    Multi-Symtpom Relief*
    Cold & Flu

    12 LOZENGES
    HOMEOPATHIC

    RESEALABLE BAG INSIDE

    NATURAL FLAVOR
    Mixed Berry

    +
    Shortens your cold
    +
    Also helps relieve:
    ✓
    Cough*
    ✓
    Congestion*
    ✓
    Sore Throat*
    +
    Gluten Free
    +
    Releases zinc ions in the mouth®
    +
    #1 pharmacist recommended zinc lozenge brand
    Cold-EEZE Plus Natural Carton Label
  • 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:46017-322
    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:46017-322-961 in 1 BOX09/12/201810/31/2022
    112 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic09/12/201810/31/2022
    Labeler - Mylan Consumer Healthcare, Inc. (831410522)
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