Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2016-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:11

Label at a glance#

ProductCold-EEZE Plus Nighttime Multi-Symptom Relief
Active ingredientZinc Gluconate, Eupatorium Perfoliatum Flowering Top, Sambucus Nigra Flower, Valerian, Chamomile, Mentha Piperita, Myrrh, Glycyrrhiza Glabra Leaf
Label structure10 sections

Indications and uses

to reduce the duration of the common cold reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest congestion, post nasal drip and/or hoarseness helps for temporary relief of Sore Throat helps to relax and sleep easier to get rested

Dosage and administration

Take Cold-EEZE ® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts ® at night when you have cold or flu symptoms Adults: Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take 1 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 Allow 6-8 hours for sleep after taking tablet For individuals un...

Storage and handling

Do not take Cold-EEZE ® Plus Nighttime Multi-Symptom Relief Cold & Flu 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

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (per tablet)Purpose
Zincum Gluconicum 1XCold Remedy
Eupatorium perfoliatum 1XFor temporary relief of flu symptoms
Sambucus nigra 1X(cough, nasal and chest congestion and irritated respiratory tract)
Valeriana Officinalis 1XSleep Disorder Remedy
Chamomile (Matricaria recutita) 2XRelaxation and Calming
Mentha Piperita 2XFor temporary relief of cough
Myrrha 2XFor temporay relief of Sore Throat
Glycyrrhiza G.L. (Licorice Root) 3XFor temporary relief of Irritated Throat

Uses

INDICATIONS & USAGE SECTION

  • to reduce the duration of the common cold
  • reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest congestion, post nasal drip and/or hoarseness
  • helps for temporary relief of Sore Throat
  • helps to relax and sleep easier to get rested

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use 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
  • are under medical supervision for diabetes or have multiple sclerosis (MS), rheumatoid arthritis (RA) or an auto-immune condition

Sore Throat Warning

SPL UNCLASSIFIED SECTION

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

Do not use

OTC - DO NOT USE SECTION

  • if taking loperamide
  • while operating a motor vehicle or machinery or consuming alcohol

OTC - STOP USE SECTION

Stop use and ask your healthcare practitioner if symptoms persist for more than 7 days or are accompanied by fever, rash or persistent headache

SPL UNCLASSIFIED SECTION

Cold-EEZE® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® is a combination product formulated to help you to sleep easier, reduce the duration of the common cold and to help for temporary relief of cold and flu symptoms. It is insufficient treatment for Influenza or Allergies.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare practitioner before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take Cold-EEZE® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® at night when you have cold or flu symptoms
  • Adults:
    • Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    • Take 1 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
  • Allow 6-8 hours for sleep after taking tablet
  • For individuals under the age of 18, consult a healthcare practitioner before use

Other information

STORAGE AND HANDLING SECTION

  • Do not take Cold-EEZE® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® on an empty stomach to avoid possible minor stomach upset
  • Store in a cool and dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural color from carrot and hibiscus concentrates, natural flavors, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 18 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Relax & Sleep!+
#1 Pharmacist Recommended

Cold-EEZE®

ZINC GLUCONATE GLYCINE

SHORTENS YOUR COLD,
WORKS FASTER®+

Plus Nighttime
Multi-Symptom Relief
Cold & Flu

ALSO HELPS RELIEVE:

  • Cough+
  • Sore Throat+
  • Chest Congestion+

Fall asleep faster,
naturally+

CLINICALLY PROVEN
INGREDIENT

18
QuickMelts®

HOMEOPATHIC
(actual
size)

NATURAL FLAVOR
Mixed Berry

PRINCIPAL DISPLAY PANEL - 18 Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 18 Tablet Blister Pack Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
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9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0231-82020-01-31C16284748780-19d75b9d0-e518-f424-e053-dadaa90a57ceCold-EEZE ® Plus Nighttime Multi-Symptom Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0231-8Cold-EEZE Plus Nighttime Multi-Symptom Relief3 in 1 CARTONTABLET, ORALLY DISINTEGRATING31
61941-0231-8Cold-EEZE Plus Nighttime Multi-Symptom Relief6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0231COLD-EEZE PLUS NIGHTTIME MULTI-SYMPTOM RELIEF (ZINC GLUCONATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, SAMBUCUS NIGRA FLOWER, VALERIAN, CHAMOMILE, MENTHA PIPERITA, MYRRH, AND GLYCYRRHIZA GLABRA LEAF) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1Legacy NDC, 2 package rows20161011_176fb319-56bb-4a31-853a-015836113441.zip

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
61941-023161941-0231-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

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
5071c8da-5b17-4ce2-bea3-e1cd03bca31d176fb319-56bb-4a31-853a-0158361134412016-07-25WarningsExact identifier
spl id: 5071c8da-5b17-4ce2-bea3-e1cd03bca31d
spl set id: 176fb319-56bb-4a31-853a-015836113441

Reported adverse events (FAERS/openFDA)#

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