FDA.reportPublic FDA data

Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2016-10-11
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 Gummies Plus Multi-Symptom Relief Cold and Flu
Active ingredientZinc Gluconate, Mentha Piperita, eupatorium perfoliatum flowering top, sambucus nigra flower, 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, congestion, post nasal drip and/or hoarseness helps for temporary relief of Sore Throat

Dosage and administration

Take Cold-EEZE ® Plus Multi-Symptom Relief Cold & Flu gummies when you have cold or flu symptoms Adults: Dissolve 2 gummies in mouth. Do not swallow whole. For best results, dissolve in your mouth. Take 2 gummies 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 12 gummies fo...

Storage and handling

Do not take Cold-EEZE ® Plus Multi-Symptom Relief Cold & Flu gummies 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 Ingredients (2 gummies)Purpose
Zincum Gluconicum 1XCold Remedy
Mentha piperita 1XFor temporary relief of cough
Sambucus nigra 2XFor temporary relief of flu symptoms
Eupatorium perfoliatum 2X(cough, congestion and irritated respiratory tract)
Myrrha 2XFor temporary relief of Sore Throat
Glycyrrhiza G. L. (Licorice Root) 2XFor 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, congestion, post nasal drip and/or hoarseness
  • helps for temporary relief of Sore Throat

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 for more than 7 days or are accompanied by fever, rash or persistent headache

Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu gummies is a combination product formulated to help you to 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.

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu gummies when you have cold or flu symptoms
  • Adults:
    • Dissolve 2 gummies in mouth. Do not swallow whole. For best results, dissolve in your mouth.
    • Take 2 gummies 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 12 gummies for adults and 8 gummies 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® Plus Multi-Symptom Relief Cold & Flu gummies on an empty stomach to avoid possible minor stomach upset
  • Store in a cool and dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, corn syrup, gelatin, glycine, maltodextrin, natural flavors and colors from fruits and vegetables, pectin and sugar (from beets)

Questions or Comments

OTC - QUESTIONS SECTION

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 - 36 gummy Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
for
Adults &
Kids 12
& up

Cold-EEZE®
ZINC GLUCONATE GLYCINE

gummies

SHORTENS YOUR COLD,
WORKS FASTER®+

Plus
Multi-Symptom
Relief
Cold & Flu

36
gummies
HOMEOPATHIC

Also Helps Relieve:

  • Cough+
  • Congestion+
  • Sore Throat+

NATURAL FLAVOR
Mixed Fruit

PRINCIPAL DISPLAY PANEL - 36 gummy Bottle Label
PRINCIPAL DISPLAY PANEL - 36 gummy Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0234-02020-01-31C16284748780-19d75b9d1-11ac-f424-e053-dadaa90a57ceCold-EEZE ® Gummies Plus Multi-Symptom Relief Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0234-0Cold-EEZE Gummies Plus Multi-Symptom Relief Cold and Flu36 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0234COLD-EEZE GUMMIES PLUS MULTI-SYMPTOM RELIEF COLD AND FLU (ZINC GLUCONATE, MENTHA PIPERITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, SAMBUCUS NIGRA FLOWER, MYRRH, AND GLYCYRRHIZA GLABRA LEAF) TABLET, ORALLY DISINTEGRATING [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20161019_fe58769f-e341-448d-8cab-573aa07d70d8.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61941-023461941-0234-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc GluconateU6WSN5SQ1ZACTIB
Mentha Piperita79M2M2UDA9ACTIB
eupatorium perfoliatum flowering top1W0775VX6EACTIB
sambucus nigra flower07V4DX094TACTIB
MYRRHJC71GJ1F3LACTIB
GLYCYRRHIZA GLABRA LEAFGH32M797Y9ACTIB
Citric Acid Monohydrate2968PHW8QPIACT
Corn Syrup9G5L16BK6NIACT
Gelatin, Unspecified2G86QN327LIACT
GlycineTE7660XO1CIACT
MALTODEXTRIN7CVR7L4A2DIACT
Pectin89NA02M4RXIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML · Source PDF

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
ef7e17d8-9690-4497-8989-9d1ef9823db1fe58769f-e341-448d-8cab-573aa07d70d82016-10-11WarningsExact identifier
spl id: ef7e17d8-9690-4497-8989-9d1ef9823db1
spl set id: fe58769f-e341-448d-8cab-573aa07d70d8

Reported adverse events (FAERS/openFDA)#

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