FDA.reportPublic FDA data

Cold-EEZE Cold Remedy

Manufacturer
Vespyr Brands Inc
Effective date
2023-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:23:30

Label at a glance#

ProductCold-EEZE Cold Remedy
Active ingredientROSA CANINA FRUIT, ECHINACEA PURPUREA, ZINC GLUCONATE
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 one chewable gel at onset of symptoms • chew slowly and dissolve completely in mouth before swallowing • do not swallow whole • do not eat or drink for 15 minutes after use • repeat every 2-4 hours until symptoms subside Adults 18 years and over do not exceed 6 chewable gels per day Children 12 to under 18 years do not exceed 4 chewable gels per day Children under 12 years ask a doctor before use

Storage and handling

each chewable gel contains : sodium 10 mg store at room temperature in a cool, dry place do not expose to excessive heat for long periods of time

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes
Zinc Gluconate 1X HPUS † (8.8%) (13.2 mg zinc).................... Cold Remedy
Rosa Caina (Rose Hips) 2X HPUS † (1.0%) ............................ Promotes immune support*
Echinacea Purpurea 1X HPUS † (0.02%)................................... Promotes immune support*
† The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

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

OTC - DO NOT USE SECTION

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and provide relief of cold and flu symptoms.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• diabetes

• multiple sclerosis (MS)

• rheumatoid arthritis (RA) or other auto-immune condition

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

OTC - WHEN USING SECTION

When using this product do not take on an empty stomach (to avoid possible minor stomach upset)

OTC - STOP USE SECTION

Stop use and ask your doctor if symptoms persist more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional 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 one chewable gel at onset of symptoms

• chew slowly and dissolve completely in mouth before swallowing
• do not swallow whole
• do not eat or drink for 15 minutes after use
• repeat every 2-4 hours until symptoms subside

Adults 18 years and overdo not exceed 6 chewable gels per day
Children 12 to under 18 yearsdo not exceed 4 chewable gels per day
Children under 12 yearsask a doctor before use

Other information

STORAGE AND HANDLING SECTION

  • each chewable gel contains: sodium 10 mg
  • store at room temperature in a cool, dry place
  • do not expose to excessive heat for long periods of time

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, corn syrup, flavors, glycine, malic acid, pectin, sambucus nigra (european elder), sucrose, sugar, tricalcium phosphate, trisodium citrate dihydrate, water

Questions?

OTC - QUESTIONS SECTION

call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold-EEZE ®

COLD REMEDY

HOMEOPATHIC

SHORTENS YOUR COLD

Plus DEFENSE*

PROMOTES Immune Health*

NATURAL FLAVOR CITRUS WITH ELDERBERRY

25 Chewable Gels

©2022 Vespyr Brands ®, Inc.

Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands ®, Inc.

East Windsor, NJ 08520

This product has not been evaluated by the FDA

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

labellabel

drug factsdrug facts

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
71179-341-252026-01-29C16284748780-149896155-a4a7-586f-e063-e6dba90add90Cold-EEZE Cold Remedy Chewable gels/gummies

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71179-341-25Cold-EEZE Cold Remedy25 in 1 BOTTLECHEWABLE GEL251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71179-341COLD-EEZE COLD REMEDY (ZINC GLUCONATE, ROSA CANINA, ECHINACEA PURPUREA) CHEWABLE GEL [VESPYR BRANDS INC]11 package rows20231114_05524b6e-d231-cd3b-e063-6394a90ad533.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71179-34171179-341-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUGARCANE81H2R5AOH3IACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
GLYCINETE7660XO1CIACT
SUCROSEC151H8M554IACT
ROSA CANINA FRUIT3TNW8D08V3ACTIB
CORN SYRUP9G5L16BK6NIACT
ECHINACEA PURPUREAQI7G114Y98ACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
MALIC ACID817L1N4CKPIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
WATER059QF0KO0RIACT
PECTIN89NA02M4RXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
5a888abf-edbb-56bf-e063-6294a90a9fe905524b6e-d231-cd3b-e063-6394a90ad5332026-09-02WarningsExact identifier
spl set id: 05524b6e-d231-cd3b-e063-6394a90ad533

Reported adverse events (FAERS/openFDA)#

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