FDA.reportPublic FDA data

Cold-EEZE

Manufacturer
ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
Effective date
2016-01-27
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 Plus Natural Multi-Symptom Relief
Active ingredientZinc Gluconate, Sambucus Nigra Flower, 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 congestion, post nasal drip and/or hoarseness helps for temporary relief of Sore Throat

Dosage and administration

Take Cold-EEZE ® Plus Natural Multi-Symptom Relief Cold & Flu Lozenges when you have cold or flu symptoms Adults: Dissolve entire lozenge in mouth. Do not chew. Do not swallow whole Take 1 lozenge 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 lozenges for adults and 4 l...

Storage and handling

Do not take Cold-EEZE ® Plus Natural Multi-Symptom Relief Cold & Flu Lozenges on an empty stomach to avoid possible minor stomach upset Store in a cool and dry place after opening; best if used within 6 months after opening

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredient (per lozenge)    Purpose
Zincum Gluconicum 2XCold Remedy
Sambucus nigra 2XFor temporary relief of flu symptoms (coughing, nasal congestion and irritated respiratory tract)
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 congestion, post nasal drip and/or hoarseness
  • helps for temporary relief of Sore Throat

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you

  • 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 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.

SPL UNCLASSIFIED SECTION

Cold-EEZE® Plus Natural Multi-Symptom Relief Cold & Flu Lozenge is a combination product formulated to help you to reduce the duration of the common cold and to help relieve Cold and Flu symptoms. 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 Natural Multi-Symptom Relief Cold & Flu Lozenges when you have cold or flu symptoms
  • Adults:
    • Dissolve entire lozenge in mouth. Do not chew. Do not swallow whole
    • Take 1 lozenge 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 lozenges for adults and 4 lozenges 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 Natural Multi-Symptom Relief Cold & Flu Lozenges on an empty stomach to avoid possible minor stomach upset
  • Store in a cool and dry place after opening; best if used within 6 months after opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn syrup, glycine, menthol, natural colors from beet and berry extracts, natural flavors and sucrose. No artificial colors or preservatives.

Questions or Comments

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 12 Lozenge Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+ SHORTENS YOUR COLD

Cold-EEZE®
Zinc Gluconate Glycine

Plus Natural
Multi-Symptom Relief

COLD & FLU

CLINICALLY PROVEN
INGREDIENT

  1. Shortens your cold, works faster®
  2. Also helps relieve:
    1. Cough
    2. Congestion
    3. Sore Throat

12
Cold Remedy
Lozenges

Homeopathic

Actual size

All Natural
Mixed Berry Flavor

Principal Display Panel - 12 Lozenge Package
Principal Display Panel - 12 Lozenge Package

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
61941-0114-42020-01-31C16284748780-19d75b9d0-80c5-f424-e053-dadaa90a57ceCold-EEZE ® Plus Natural Multi-Symptom Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61941-0114-4Cold-EEZE Plus Natural Multi-Symptom Relief12 in 1 PACKAGELOZENGE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61941-0114COLD-EEZE PLUS NATURAL MULTI-SYMPTOM RELIEF (ZINC GLUCONATE, SAMBUCUS NIGRA FLOWER, AND GLYCYRRHIZA GLABRA LEAF) LOZENGE [PROPHASE LABS, INC.]1Legacy NDC, 1 package rows20160204_e687c0ef-4afe-45d7-bedd-5c3ff5ea97df.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61941-011461941-0114-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc GluconateU6WSN5SQ1ZACTIB
Sambucus Nigra Flower07V4DX094TACTIB
Glycyrrhiza Glabra LeafGH32M797Y9ACTIB
Corn Syrup9G5L16BK6NIACT
GlycineTE7660XO1CIACT
Menthol, Unspecified FormL7T10EIP3AIACT
SucroseC151H8M554IACT

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Cold Therapy Citrus FlavorZINC GLUCONATERARITAN PHARMACEUTICALS INCb859382d-9fa6-4cf1-b659-95b863f68d582026-09-08WarningsName fallback
generic name: ZINC GLUCONATE
Zinc Cold therapyZINC GLUCONATETHE KROGER CO.,e2d22c18-a32a-4bf6-8ee2-78ae3e41ba962026-09-01WarningsName fallback
generic name: ZINC GLUCONATE
CVS Health Cold Remedy Citrus FlavorZINC GLUCONATECVS PHARMACY, INCd32dedd1-8db8-427e-a925-fe5ebb5498802026-08-13WarningsName fallback
generic name: ZINC GLUCONATE
Cold-EEZE Cold RemedyZINC GLUCONATEVespyr Brands LLC016937dd-6599-849a-e063-6294a90a24d32026-05-01WarningsName fallback
generic name: ZINC GLUCONATE
Cold-EEZE Cold Remedy UltraMELT ChewsZINC GLUCONATEVespyr Brands LLC04b6992d-c7c5-56c7-e063-6394a90ae8d02026-05-01WarningsName fallback
generic name: ZINC GLUCONATE
COLD EEZEZINC GLUCONATEJHK Inc dba American Safety & First Aide6e729c0-90ee-410e-b425-9c19e3333a242025-12-16WarningsName fallback
generic name: ZINC GLUCONATE
Zinc Cold TherapyZINC GLUCONATEChain Drug Manufacturing Assn9b2bafda-29f7-4e4b-9f9d-b2ebaf4ef7052025-12-03WarningsName fallback
generic name: ZINC GLUCONATE
TopCare Zinc Cold Remedy Citrus FlavorZINC GLUCONATETOPCO ASSOCIATES LLCf94a9846-5239-4e1b-93a4-c00a9dd36aba2025-11-10WarningsName fallback
generic name: ZINC GLUCONATE
Target Zinc Cold Therapy Citrus FlavorZINC GLUCONATETARGET CORPORATION3219cd62-25e9-4a13-938f-eace684cfadd2025-11-04WarningsName fallback
generic name: ZINC GLUCONATE
Zinc Cold TherapyZINC GLUCONATEBETTER LIVING BRANDS LLC4ad45191-a1ce-42b3-86f8-b2d212804f0a2025-10-29WarningsName fallback
generic name: ZINC GLUCONATE
Zinc Cold TherapyZINC GLUCONATEBETTER LIVING BRANDS LLC4bd136d8-b001-4a16-9429-4a7f0921acb82025-10-29WarningsName fallback
generic name: ZINC GLUCONATE
ZincZINC GLUCONATEWal-Mart Stores,Inc.,ef4d82f6-2b77-41cd-9f4a-86ca9906a00d2025-10-27WarningsName fallback
generic name: ZINC GLUCONATE
Meijer Cold Therapy Citrus FlavorZINC GLUCONATEMeijer Distribution Incd2629578-c0a4-417c-9b60-f4bad617321f2025-10-24WarningsName fallback
generic name: ZINC GLUCONATE
First Aid Direct Cold-EEZE Cold RemedyZINC GLUCONATECintas Corporationa6c5906d-8f04-42f7-885f-e7490ec6b5bc2025-09-23WarningsName fallback
generic name: ZINC GLUCONATE
Medique Cold EezeZINC GLUCONATEUnifirst First Aid Corporationa2b5f20a-87bf-731f-e053-2995a90a19522025-09-09WarningsName fallback
generic name: ZINC GLUCONATE
Premier Value Zinc Cold Therapy Citrus FlavorZINC GLUCONATEPHARMACY VALUE ALLIANCE, LLC88d9d0ac-15a4-4ae1-93f6-31dfd21951492024-10-28WarningsName fallback
generic name: ZINC GLUCONATE

Reported adverse events (FAERS/openFDA)#

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