Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2014-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:19

Label at a glance#

ProductCold-EEZE Daytime and Nighttime QuickMelts
Active ingredientZinc Gluconate, VALERIAN, Chamomile
Label structure18 sections

Indications and 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.

Dosage and administration

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 f...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cold-EEZE® Daytime QuickMelts® (AM)

Drug Facts

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Zincum Gluconicum 1X

Purpose

OTC - PURPOSE SECTION

Cold Remedy

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines.

OTC - STOP USE SECTION

Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

OTC - WHEN USING SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor before using Cold-EEZE®

OTC - ASK DOCTOR SECTION

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.

OTC - STOP USE SECTION

Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

OTC - WHEN USING SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - Kit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0225-42020-01-31C16284748780-19d75b9cf-d5fe-f424-e053-dadaa90a57ceCold-EEZE ® Daytime/Nighttime QuickMelts ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0225-4Cold-EEZE Daytime and Nighttime QuickMelts1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0225COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS (ZINC GLUCONATE, VALERIAN, AND CHAMOMILE) KIT [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20150114_42739447-8fa8-4f03-9035-2e44671feb04.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ChamomileACTIVE INGREDIENTFGL3685T2X1
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
Zinc GluconateACTIVE INGREDIENTU6WSN5SQ1Z1
ChamomileACTIVE MOIETYFGL3685T2X1
VALERIANACTIVE MOIETYJWF5YAW3QW1
ZINC CATIONACTIVE MOIETY13S1S8SF371
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CrospovidoneINACTIVE INGREDIENT68401960MK1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GlycineINACTIVE INGREDIENTTE7660XO1C1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MALIC ACIDINACTIVE INGREDIENT817L1N4CKP1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21
STEVIA REBAUDIUNA LEAFINACTIVE INGREDIENT6TC6NN08761
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TALCINACTIVE INGREDIENT7SEV7J4R1U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61941-022561941-0225-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 396 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED, EXTENDED RELEASE / ORAL543 mgExact identifier — unii candidate
65 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
15 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ALOZENGE / ORAL20546 mgExact identifier — unii candidate
65 equally ranked IID candidates
GlycineGLYCINETE7660XO1CPOWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
20 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGEL / OPHTHALMIC25 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1568 mgExact identifier — unii candidate
65 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycineGLYCINETE7660XO1CPASTE, DENTIFRICE / DENTAL0.34 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS180 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE, EXTENDED RELEASE / ORAL616 mgExact identifier — unii candidate
65 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, SOLUTION / INTRAVENOUS0.42 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycineGLYCINETE7660XO1CCAPSULE / ORAL62 mgExact identifier — unii candidate
20 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3.76 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
GlycineGLYCINETE7660XO1CCAPSULE, DELAYED RELEASE / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, EXTENDED RELEASE / ORAL320 mgExact identifier — unii candidate
42 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii candidate
28 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
GlycineGLYCINETE7660XO1CTABLET, CHEWABLE / ORAL267 mgExact identifier — unii candidate
20 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE / ORAL1328 mgExact identifier — unii candidate
65 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / BUCCAL0.01 mgExact identifier — unii candidate
11 equally ranked IID candidates
MALIC ACIDMALIC ACID817L1N4CKPPOWDER, FOR SUSPENSION / ORAL1392 mgExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii candidate
42 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
65 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c1cf8137-5dad-44d8-b08d-5404467e05b042739447-8fa8-4f03-9035-2e44671feb042014-11-25WarningsExact identifier
spl id: c1cf8137-5dad-44d8-b08d-5404467e05b0
spl set id: 42739447-8fa8-4f03-9035-2e44671feb04

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.