FDA.reportPublic FDA data

Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2016-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:30

Label at a glance#

ProductCold-EEZE Natural Allergy Relief
Active ingredientOnion, Eupatorium Perfoliatum Flowering Top, Buckwheat, Symplocarpus Foetidus Root, Sambucus Nigra Flower, Tussilago Farfara Leaf, Urtica Dioica, Zinc Gluconate
Label structure11 sections

Indications and uses

For temporary relief of symptoms associated with allergies: Breathing difficulties, headache, congestion, itchy eyes, runny nose, stuffy nose and bronchial spasms

Dosage and administration

Take Cold-EEZE ® Natural Allergy Symptom Relief when you have allergy symptoms For ages 12 years and older: Take 1 caplet with water Repeat every 8-12 hours as needed until all symptoms subside Do Not Take more than 3 caplets per day Recommended daily dose is 2 caplets per day For individuals under the age of 12, consult a healthcare practitioner before use

Storage and handling

Do not crush or divide the Cold-EEZE ® Natural Allergy Symptom Relief caplets Store in a dark, cool and dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (per caplet)

OTC - ACTIVE INGREDIENT SECTION

Allium Cepa L 2X
Eupatorium perfoliatum 1X
Polygonum fagopyrum L. 2X
Pothos Foetidus 2X
Sambucus nigra 1X
Tussilago petasites L.1X
Urtuca dioica 1X
Zincum Gluconicum 2X

Purpose

OTC - PURPOSE SECTION

For temporary relief of symptoms associated with allergies

Uses

INDICATIONS & USAGE SECTION

For temporary relief of symptoms associated with allergies: Breathing difficulties, headache, congestion, itchy eyes, runny nose, stuffy nose and bronchial spasms

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you

  • Are on anticoagulant therapy, barbiturates, or are under medical supervision for diabetes and are taking diabetes medication, as sambucus nigra (Elder Flower) can decrease blood sugar levels

OTC - STOP USE SECTION

Stop use and ask your healthcare practitioner if you have noticed any allergic reaction or rashes or if symptoms persist beyond 5 days.

SPL UNCLASSIFIED SECTION

Cold-EEZE® Natural Allergy Relief is formulated to help you with temporary relief of symptoms associated with indoor/outdoor and seasonal 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® Natural Allergy Symptom Relief when you have allergy symptoms
  • For ages 12 years and older:
    • Take 1 caplet with water
    • Repeat every 8-12 hours as needed until all symptoms subside
    • Do Not Take more than 3 caplets per day
  • Recommended daily dose is 2 caplets per day
  • For individuals under the age of 12, consult a healthcare practitioner before use

Other information

STORAGE AND HANDLING SECTION

  • Do not crush or divide the Cold-EEZE® Natural Allergy Symptom Relief caplets
  • Store in a dark, cool and dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbopol, dibasic calcium phosphate, magnesium stearate, methocel, microcrystalline cellulose, silicon dioxide, stearic acid.

Questions or Comments

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

From the makers of
Cold-EEZE®

NATURAL
ALLERGY
RELIEF™

Up to 12 Hours Extended-Release

For Relief of:

  1. Congestion
  2. Itchy Eyes
  3. Runny Nose
    & Stuffy Nose

Non
Drowsy

20
Coated
Caplets

Homeopathic

Actual size

For Indoor
& Outdoor
Allergies

Principal Display Panel - 20 Caplet Blister Pack Box
Principal Display Panel - 20 Caplet Blister Pack Box

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61941-0229-42020-01-31C16284748780-19d75b9d0-8b69-f424-e053-dadaa90a57ceCold-EEZE ® Natural Allergy Relief™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0229-1Cold-EEZE Natural Allergy Relief10 in 1 BLISTER PACKTABLET, DELAYED RELEASE101
61941-0229-4Cold-EEZE Natural Allergy Relief2 in 1 BOXTABLET, DELAYED RELEASE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0229COLD-EEZE NATURAL ALLERGY RELIEF (ONION, EUPATORIUM PERFOLIATUM FLOWERING TOP, BUCKWHEAT, SYMPLOCARPUS FOETIDUS ROOT, SAMBUCUS NIGRA FLOWER, TUSSILAGO FARFARA LEAF, URTICA DIOICA, AND ZINC GLUCONATE) TABLET, DELAYED RELEASE [PROPHASE LABS, INC.]1Legacy NDC, 2 package rows20160205_aa3db5f9-cade-4d4f-b928-a619a6813391.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61941-022961941-0229-1, 61941-0229-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Onion492225Q21HACTIB
Eupatorium Perfoliatum Flowering Top1W0775VX6EACTIB
BuckwheatN0Y68724R3ACTIB
Symplocarpus Foetidus RootR88254608WACTIB
Sambucus Nigra Flower07V4DX094TACTIB
Tussilago Farfara LeafG2GH7V846ZACTIB
Urtica Dioica710FLW4U46ACTIB
Zinc GluconateU6WSN5SQ1ZACTIB
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)4Q93RCW27EIACT
Calcium Phosphate, Dibasic, DihydrateO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
Methylcellulose (25 MPA.S)BI55GG2WLIIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
Stearic Acid4ELV7Z65APIACT

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
7f819f4d-23b8-4b25-b6ae-f8755914db72aa3db5f9-cade-4d4f-b928-a619a68133912016-01-28WarningsExact identifier
spl id: 7f819f4d-23b8-4b25-b6ae-f8755914db72
spl set id: aa3db5f9-cade-4d4f-b928-a619a6813391

Reported adverse events (FAERS/openFDA)#

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