FDA.reportPublic FDA data

Cold-EEZE Cold Remedy UltraMELT Chews

Manufacturer
Vespyr Brands LLC
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:28

Label at a glance#

ProductCold-EEZE Cold Remedy UltraMELT Chews
Active ingredientZINC GLUCONATE
Label structure9 sections

Indications and uses

reduces the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

Dosage and administration

• take one chewable tablet at the 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 tablets per day Children 12 to under 18 years do not exceed 4 chewable tablets per day Children under 12 years ask a doctor before use

Storage and handling

store in a cool, dry place after opening best if used within 6 months after opening

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per tablet )
Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc)

† The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Purposes

OTC - PURPOSE SECTION

Cold remedy

Uses

INDICATIONS & USAGE SECTION

  • reduces the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

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 its symptoms.

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 tablet at the 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 tablets per day
Children 12 to under 18 yearsdo not exceed 4 chewable tablets per day
Children under 12 yearsask a doctor before use

Other information

STORAGE AND HANDLING SECTION

  • store in a cool, dry place after opening
  • best if used within 6 months after opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, erythritol, FD&C red no. 40 aluminum lake, FD&C yellow No. 5 (tartrazine) aluminum lake, glycine, hydroxypropyl cellulose, isomalt, magnesium stearate, natural flavors, sucarlose, xylitol

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold-EEZE ®

COLD REMEDY

ZINC GLUCONATE HOMEOPATHIC

SHORTENS YOUR COLD ®

UltraMELT ® Chews

GREAT Tasting

QUICK DISSOLVING Tablets

NATURAL ORANGE FLAVOR

24 Chewable Tablets

©2022 Vespyr Brands ®, Inc.

Cold-EEZE ® and ULTRAMELT ® are registered trademarks of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands ®, Inc.

East Windsor, NJ 08520 USA

This product has not been evaluated by the FDA

Made in Denmark

www.coldeeze.com

labellabel

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71179-350-24Cold-EEZE Cold RemedyUltraMELT Chews12 in 1 BLISTER PACKTABLET, CHEWABLE123
71179-350-24Cold-EEZE Cold RemedyUltraMELT Chews2 in 1 BOXTABLET, CHEWABLE23

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71179-35071179-350-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCINETE7660XO1CIACT
SUCRALOSE96K6UQ3ZD4IACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
ZINC GLUCONATEU6WSN5SQ1ZACTIB
XYLITOLVCQ006KQ1EIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM STEARATE70097M6I30IACT
ISOMALTS870P55O2WIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
ERYTHRITOLRA96B954X6IACT
FD&C RED NO. 40WZB9127XOAIACT

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
Cold-EEZE Cold Remedy UltraMELT ChewsZINC GLUCONATEVespyr Brands LLC04b6992d-c7c5-56c7-e063-6394a90ae8d02026-05-01WarningsExact identifier
ndc (package): 71179-350-24
ndc (product): 71179-350
ndc11 (package): 71179035024
spl id: 514358e2-3cb7-5306-e063-6294a90a59bb
spl set id: 04b6992d-c7c5-56c7-e063-6394a90ae8d0

Reported adverse events (FAERS/openFDA)#

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