FDA.reportPublic FDA data

Medique ColdEeze

Manufacturer
Unifirst-First Aid Corporation | Medique Products
Effective date
2020-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:12:28

Label at a glance#

ProductMedique ColdEeze
Active ingredientZINC GLUCONATE
Label structure11 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

Dosage and administration

take one lozenge at the onset of symptoms dissolve entire lozenge in mouth do not chew 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 lozenges per day Children 12 years to under 18 years: do not exceed 4 lozenges per day Children under 12 years: ask a doctor before use

Label contents#

Full prescribing information#

Active ingredient (per lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zincum Gluconicum 2X HPUS (2.3%) (13.3mg Zinc)

The letters 'HPUS' indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United Staes.

Purpose

OTC - PURPOSE SECTION

Cold Remedy

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cols and its symptoms.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR SECTION

taking minocycline, doxycycline, tetracycline or are on Coumadin (wafarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

Stop use and ask your doctor if

OTC - STOP USE SECTION

symptoms persist beyond 7 days.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare practitioner before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take one lozenge at the onset of symptoms
  • dissolve entire lozenge in mouth
  • do not chew
  • 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 lozenges per day

Children 12 years to under 18 years: do not exceed 4 lozenges per day

Children under 12 years: ask a doctor before use

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, glycine, natural flavors, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

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

Medique Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique®

The # 1 Best Selling Zinc Lozenge Brand*

Cold-EEZE®

Zinc Gluconate Homeopathic

Pull To Open

Shortens Your Cold

# 1 Pharmacist Recommended

(actual size)

Natural Cherry Flavor

25 LOZENGES

4587345873

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47682-758-732022-01-28C16284748780-1d6a99b39-a111-a426-e053-dadaa90af4c2Medique COLD-EEZE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-758-73Medique ColdEeze25 in 1 BOXLOZENGE252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-758MEDIQUE COLDEEZE (ZINC GLUCONATE) LOZENGE [UNIFIRST-FIRST AID CORPORATION]2Legacy NDC, 1 package rows20200317_9db15691-1cb4-3804-e053-2a95a90a5d55.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-75847682-758-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN SYRUP9G5L16BK6NIACT
GLYCINETE7660XO1CIACT
SUCROSEC151H8M554IACT
ZINC GLUCONATEU6WSN5SQ1ZACTIB

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
a0859051-515e-0f4a-e053-2a95a90a1f2b9db15691-1cb4-3804-e053-2a95a90a5d552020-03-10WarningsExact identifier
spl id: a0859051-515e-0f4a-e053-2a95a90a1f2b
spl set id: 9db15691-1cb4-3804-e053-2a95a90a5d55

Reported adverse events (FAERS/openFDA)#

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