Label: COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS- zinc gluconate, valerian, and chamomile kit

  • NDC Code(s): 46017-329-44
  • 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 January 4, 2018

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

  •  

    Cold-EEZE® Daytime QuickMelts® (AM)

    Drug Facts

  • Active ingredient (per tablet)

    Zincum Gluconicum 1X

  • Purpose

    Cold Remedy

  • Uses

    to reduce the duration of the common cold
    reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
  • Warnings

  • Ask a doctor before use if you

    are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines
  • Stop use and ask your healthcare practitioner

    if symptoms persist beyond 7 days

    Cold-EEZE® QuickMelts® Daytime is formulated to reduce the duration of the common cold and its 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

  • Directions

    Take Cold-EEZE® Daytime QuickMelts® when you have cold symptoms
    Adults and children 12 years and over:
    o
    Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    o
    Take 1 tablet at the onset of symptoms
    o
    Repeat every 2-4 hours as needed until all symptoms subside
    o
    Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
    o
    Recommended daily dose is 6 tablets for adults and 4 tablets for ages 12-17 years
    For children under 12 years of age, consult a healthcare practitioner before use
  • Other information

    Do not take Cold-EEZE® QuickMelts® on an empty stomach to avoid possible minor stomach upset
    Store in a cool and dry place
  • Inactive ingredients

    crospovidone, FD&C Red #40, glycine, magnesium stearate, malic acid, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose, talc

  • Cold-EEZE® Nighttime QuickMelts® (PM)

    Drug Facts

  • Active ingredients (per tablet)

    Zincum Gluconicum 1X

    Valeriana Officinalis 1X

    Chamomile (Matricaria recutita) 2X

  • Purpose

    Cold Remedy

    Sleep Disorder Remedy

    Relaxation and Calming

  • Uses

    to reduce the duration of the common cold
    reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
    helps to relax and sleep easier to get rested
  • Warnings

  • Ask a doctor before using Cold-EEZE®

    Nighttime QuickMelts® 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

    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 beyond 7 days

    Cold-EEZE® Nighttime QuickMelts® is a combination product formulated to help you to sleep easier and to reduce the duration of the common cold and its symptoms.

    It is insufficient treatment for Influenza or Allergies.

    Allow 6-8 hours for sleep after taking tablet

  • 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® Nighttime QuickMelts® at night when you have cold symptoms
    Adults:
    o
    Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    o
    Take 1 Nighttime tablet 1 hour before bedtime
    o
    Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
    o
    Recommended dose is 1 tablet for adults
    For individuals under the age of 18, consult a healthcare practitioner before use
  • Other information

    Do not take Cold-EEZE® QuickMelts® on an empty stomach to avoid possible minor stomach upset
    Store in a cool and dry place
  • Inactive ingredients

    crospovidone, FD&C Blue #1 & #2, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, sodium lauryl sulfate, silicon dioxide, sodium starch glycolate, stevia, sucralose, talc

    Relax & Sleep Natural Nighttime Formula:

    +
    Chamomile and Valerian to help you relax and fall asleep faster, naturally
    +
    Shortens your cold, works faster®
    +
    Natural Herbal Extracts
    +
    Gluten Free
    +
    Dissolves quickly in the mouth without water
    +
    Releases zinc ions in the mouth
  • Questions or Comments

    Call 1-800-505-2653
    (M-F: 8AM-5PM ET)
    www.ColdEEZE.com

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

    Mylan.com

    +THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.

    CEZ:329:44:CT:R1

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC 46017-329-44

    #1 Pharmacist Recommended

    Cold-EEZE®
    ZINC GLUCONATE GLYCINE

    SHORTENS YOUR COLD WORKS FASTER®+

    DAYTIME
    NIGHTTIME

    18 QuickMelts®
    DAYTIME:

    Shortens your cold, works faster®+
    Non-Drowsy

    6 QuickMelts®
    NIGHTTIME:

    Shortens your cold, works faster®+
    Fall asleep faster+, naturally
    Non-habit forming

    NATURAL FLAVOR
    Mixed Berry
    Homeopathic QuickMelts®

    Cold-EEZE Daytime and Nighttime Quick Melt Carton
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE  DAYTIME AND NIGHTTIME QUICKMELTS
    zinc gluconate, valerian, and chamomile kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-329
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46017-329-441 in 1 CARTON; Type 0: Not a Combination Product02/13/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 18 
    Part 21 BLISTER PACK
    Part 1 of 2
    COLD-EEZE  DAYTIME QUICKMELTS
    zinc gluconate tablet, orally disintegrating
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Glycine (UNII: TE7660XO1C)  
    MALIC ACID (UNII: 817L1N4CKP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOCTAGON (8 sided)Size15mm
    FlavorBERRY (mixed berry) Imprint Code AM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/13/201910/31/2022
    Part 2 of 2
    COLD-EEZE  NIGHTTIME QUICKMELTS
    zinc gluconate, valerian, and chamomile tablet, orally disintegrating
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]
    Chamomile (UNII: FGL3685T2X) (Chamomile - UNII:FGL3685T2X) Chamomile2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Glycine (UNII: TE7660XO1C)  
    MALIC ACID (UNII: 817L1N4CKP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOCTAGON (8 sided)Size15mm
    FlavorBERRY (mixed berry) Imprint Code PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/13/201910/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/13/201910/31/2022
    Labeler - Mylan Consumer Healthcare, Inc. (831410522)