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

  • NDC Code(s): 46017-343-25
  • 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 October 29, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredients (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.

  • Purposes

    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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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

  • Principal Display Panel – Mixed Berry

    NDC 46017-343-25

    Cold-EEZE®
    COLD REMEDY

    HOMEOPATHIC

    SHORTENS YOUR COLD®

    Plus COLD & FLU SYMPTOM RELIEF*

    HELPS RELIEVE Cough,
    Congestion, Sore Throat*

    25
    Lozenges

    NATURAL MIXED
    BERRY FLAVOR

    Shortens your cold
    Gluten free
    No artificial colors or preservatives
     
    Also helps relieve:
    Cough*
    Congestion*
    Sore throat*

    Learn more about Cold-EEZE®
    at www.coldeeze.com

    Releases zinc ions
    in the mouth® and
    shortens the duration
    of the common cold
    Pharmacist
    recommended
    zinc lozenge brand

    UC-34325-25-01

    ©2020 Mylan Inc.

    Manufactured for:
    Mylan Consumer
    Healthcare, Inc.

    Morgantown,
    WV 26505 U.S.A.

    Mylan.com

    Cold-EEZE Cold& Flu Symptom Relief
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE  PLUS COLD AND FLU SYMPTOM RELIEF
    zinc gluconate, sambucus nigra flower, and glycyrrhiza glabra leaf lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-343
    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)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize23mm
    FlavorBERRY (mixed berry) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46017-343-251 in 1 BOX06/12/202010/31/2022
    125 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/12/202010/31/2022
    Labeler - Mylan Consumer Healthcare, Inc. (831410522)