Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc. | Blispak, Inc.
Effective date
2013-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:59

Label at a glance#

ProductCold-EEZE PLUS Immune Support
Active ingredientZinc Gluconate, ROSA CANINA LEAF, ECHINACEA PURPUREA
Label structure9 sections

Indications and 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. supports immune system health.

Dosage and administration

Take Cold-EEZE ® Plus Immune Support QuickMelts ® when you have cold symptoms. Adults: 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. For individuals under the age of...

Storage and handling

Do not take on an empty stomach to avoid possible minor stomach upset. Echinacea might cause a slight tingling sensation on the tongue. Store in a cool and dry place.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (per tablet)Purpose
Zincum Gluconicum 1XCold Remedy
Rosa Canina L. (Rose Hip) 1XPromotes Immune support
Echinacea Purpurea Extract 2XPromotes Immune support

Uses

INDICATIONS & USAGE SECTION

  • 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.
  • supports immune system health.

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.
  • are under medical supervision for diabetes or have a skin condition called pemphigus vulgaris or have multiple sclerosis (MS), rheumatoid arthritis (RA), or an auto-immune condition.

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

Cold-EEZE® Plus Immune Support QuickMelts® is a combination product formulated to help you to reduce the duration of the common cold and its symptoms and promote immune system health. It 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® Plus Immune Support QuickMelts® when you have cold symptoms.
  • Adults:
    • 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.
  • For individuals under the age of 18, consult a healthcare practitioner before use.

Other information

STORAGE AND HANDLING SECTION

  • Do not take on an empty stomach to avoid possible minor stomach upset.
  • Echinacea might cause a slight tingling sensation on the tongue.
  • Store in a cool and dry place.

Other ingredients

INACTIVE INGREDIENT SECTION

beta carotene, crospovidone, glycine, magnesium stearate, malic acid, mannitol, microcrystalline cellulose, natural menthol flavor, natural orange flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate sodium starch glycolate, stevia, sucralose, talc.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 24 Tablet Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW QuickMelts®

GREAT
TASTE

Cold-EEZE®

Zinc Gluconate Glycine

COLD REMEDY

Plus Natural
Immune Support

  • Shortens Your Cold, Works Faster
  • Promotes Immune Health,
    Antioxidant Support
    • Rose Hips: Rich in Natural Vitamin C
    • Echinacea

24 QuickMelts®
Homeopathic

Natural
Orange Flavor

Principal Display Panel - 24 Tablet Package
Principal Display Panel - 24 Tablet Package

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0223-42019-11-27C16284748780-19855d018-e45c-cd31-e053-dbdaa90ab51aCold-EEZE ® PLUS Immune Support

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0223-1Cold-EEZE PLUS Immune Support6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61
61941-0223-4Cold-EEZE PLUS Immune Support4 in 1 PACKAGETABLET, ORALLY DISINTEGRATING41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0223COLD-EEZE PLUS IMMUNE SUPPORT (ZINC GLUCONATE, ROSA CANINA LEAF, AND ECHINACEA PURPUREA) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1Legacy NDC, 2 package rows20130928_d75c93c1-314b-484b-b8ad-29def45d0e0e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ECHINACEA PURPUREAACTIVE INGREDIENTQI7G114Y981
ROSA CANINA LEAFACTIVE INGREDIENTJ3N2Z889QP1
Zinc GluconateACTIVE INGREDIENTU6WSN5SQ1Z1
ECHINACEA PURPUREAACTIVE MOIETYQI7G114Y981
ROSA CANINA LEAFACTIVE MOIETYJ3N2Z889QP1
Zinc CationACTIVE MOIETY13S1S8SF371
.BETA.-CAROTENEINACTIVE INGREDIENT01YAE03M7J1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1
GLYCINEINACTIVE INGREDIENTTE7660XO1C1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MALIC ACIDINACTIVE INGREDIENT817L1N4CKP1
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
ORANGEINACTIVE INGREDIENT5EVU04N5QU1
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 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61941-022361941-0223-1, 61941-0223-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 6 · 331 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii candidate
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SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
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TALCTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii candidate
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MENTHOLMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
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TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
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SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
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TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
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SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii candidate
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TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
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SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR105 mgExact identifier — unii candidate
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SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
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SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
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MENTHOLMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
65 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, CHEWABLE / ORAL267 mgExact identifier — unii candidate
20 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
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CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36AWAFER / ORAL642 mgExact identifier — unii candidate
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SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
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SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36ASOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
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GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
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CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
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MALIC ACIDMALIC ACID817L1N4CKPSOLUTION / ORAL16760 mgExact identifier — unii candidate
5 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / OPHTHALMICNAExact identifier — unii candidate
24 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
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TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
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2 equally ranked IID candidates
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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
8c9e0e83-058b-4f5a-899f-03a0f80033c0d75c93c1-314b-484b-b8ad-29def45d0e0e2013-08-22WarningsExact identifier
spl id: 8c9e0e83-058b-4f5a-899f-03a0f80033c0
spl set id: d75c93c1-314b-484b-b8ad-29def45d0e0e

Reported adverse events (FAERS/openFDA)#

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