Label: COLD-EEZE COLD REMEDY- zinc gluconate, sambucus nigra, avena sativa l., rosa canina, echinacea purpurea lozenge

  • NDC Code(s): 71179-323-12, 71179-323-25
  • Packager: Vespyr Brands 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 April 12, 2023

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  • Drug Facts

  • Active ingredients

    Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes
    Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc).................. Cold Remedy
    Sambucus Nigra 1X HPUS † (1.11%) ......................................... Promotes immune support*
    Avena Sativa L. 2X HPUS † (0.14%) ............................................ Helps with general debility and fatigue*

    Rosa Canina (Rose Hips) 2X HPUS † (0.09%) ........................ Promotes immune support*

    Echinacea Purpurea 3X HPUS † (0.04%) .................................. Promotes immune support*
    † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

  • Purposes

    Purposes

  • 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
    • supports immune system health*
    • helps with general debility and fatigue*
  • Warnings

    Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its 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 more than 7 days

    If pregnant or breastfeeding, ask a healthcare professional 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 chew
    • dissolve entire lozenge in mouth • do not swallow whole
    • do not eat or drink for 15 minutes after use
    • repeat every 2-4 hours until symptoms subside

    Adults 18 years and overdo not exceed 6 lozenges per day
    Children 12 to under 18 yearsdo not exceed 4 lozenges per day
    Children under 12 yearsask 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, sucrose

  • Questions or comments?

    call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Cold-EEZE ®

    COLD REMEDY

    HOMEOPATHIC

    Plus DEFENSE*

    PROMOTES Immune Health*

    HELPS with Fatigue*

    NATURAL FLAVOR CITRUS with ELDERBERRY

    12 Lozenges

    ©2023 Vespyr Brands ®, Inc.

    All rights reserved

    Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.

    Distributed by Vespyr Brands ®, Inc.

    East Windsor, NJ 08520

    This product has not been evaluated by the FDA

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

    label

  • INGREDIENTS AND APPEARANCE
    COLD-EEZE COLD REMEDY 
    zinc gluconate, sambucus nigra, avena sativa l., rosa canina, echinacea purpurea lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71179-323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE13.3 mg
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER50 mg
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP6.2 mg
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3) (ROSA CANINA FRUIT - UNII:3TNW8D08V3) ROSA CANINA FRUIT4 mg
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCINE (UNII: TE7660XO1C)  
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeOVALSize23mm
    FlavorCITRUS (with Elderberry) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71179-323-2525 in 1 BOX05/09/2022
    11 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:71179-323-1212 in 1 BOX04/12/2023
    21 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    Labeler - Vespyr Brands Inc (118094893)
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