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

  • Category: HUMAN OTC DRUG LABEL

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 November 25, 2014

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  • SPL UNCLASSIFIED SECTION

    Cold-EEZE® Daytime QuickMelts® (AM)

    Drug Facts

  • Active ingredient (per tablet)

    Zincum Gluconicum 1X

  • Purpose

    Cold Remedy

  • Uses

    Take 1 QuickMelt every 2-4 hours per Directions on inside panel.

    • 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 and is insufficient treatment for Influenza or Allergies.

    If pregnant or breast feeding, 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:
      • Dissolve entire tablet in mouth. Do not chew.
        Do not swallow whole.
      • Take 1 tablet at the onset of symptoms.
      • Repeat every 2-4 hours as needed until all symptoms subside.
      • Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids.
      • 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.

  • SPL UNCLASSIFIED SECTION

    Cold-EEZE® Nighttime QuickMelts® (PM)

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (per tablet)Purpose
    Zincum Gluconicum 1XCold Remedy
    Valeriana Officinalis 1XSleep Disorder Remedy
    Chamomile (Matricaria recutita) 2XRelaxation and Calming
  • Uses

    Take 1 Nighttime QuickMelt 1 hour before bedtime per Directions on inside panel.

    • 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 take concomitantly with loperamide.

    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 and is insufficient treatment for Influenza or Allergies.

    Do not take Cold-EEZE® Nighttime QuickMelts® while operating a motor vehicle or machinery or consuming alcohol.

    Allow 6-8 hours for sleep after taking tablet.

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

    Keep out of reach of children.

  • Directions

    • Take Cold-EEZE® Nighttime QuickMelts® at night when you have cold symptoms.
    • Adults;
      • Dissolve entire tablet in mouth. Do not chew.
        Do not swallow whole.
      • Take 1 Nighttime tablet 1 hour before bedtime.
      • Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids.
    • 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.

  • Questions or Comments

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NEW QuickMelts®

    GREAT
    TASTE

    Cold-EEZE®
    Zinc Gluconate Glycine
    COLD REMEDY

    CLINICALLY PROVEN
    INGREDIENT

    Daytime
    Nighttime
    #1 Pharmacist Recommended

    Daytime

    ﹢
    Shortens your cold,
    works faster™
    ﹢
    Non-drowsy

    Nighttime

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

    18 MELTS
    (Daytime)

    QuickMelts®
    Natural
    Mixed Berry Flavor
    Homeopathic

    6 MELTS
    (Nighttime)

    Principal Display Panel - Kit 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:61941-0225
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0225-41 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 18 
    Part 21 BLISTER PACK 6 
    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: 68401960MK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (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)  
    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 homeopathic12/01/2014
    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: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (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)  
    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 homeopathic12/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic12/01/2014
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL(61941-0225) , ANALYSIS(61941-0225) , REPACK(61941-0225)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998MANUFACTURE(61941-0225) , PACK(61941-0225) , REPACK(61941-0225)
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