FDA.reportPublic FDA data

COLD EEZE

Manufacturer
JHK Inc dba American Safety & First Aid
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:56

Label at a glance#

ProductCOLD EEZE
Active ingredientZINC GLUCONATE
Label structure10 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 lozenge at the onset of symptoms Dissolve the entire lozenge in the 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 - 18 years - do not exceed 4 lozenges 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (per lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zinc Gluconate 2X HPUS (2.3%) (13.3mg Zinc)

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

Purpose

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. The product is only intended 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 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 beyond 7 days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health 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 lozenge at the onset of symptoms
  • Dissolve the entire lozenge in the 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 - 18 years - do not exceed 4 lozenges per day
Children under 12 years - ask 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

Corn syrup, glycine, natural flavors and sucrose

Questions?

OTC - QUESTIONS SECTION

1-800-505-2653 Mon.- Fri. 8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 25 Lozenge Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product# 1242

Cold-EEZE®

ZINC GLUCONATE HOMEOPATHIC

  • Take Cold-EEZE® at the first
    sign of a cold
  • Continue until symptoms are gone
  • Gluten Free

SHORTENS YOUR COLD

CLINICALLY TESTED
to shorten colds by 42%*

25 LOZENGES

NATURAL
CHERRY FLAVOR

PRINCIPAL DISPLAY PANEL - 25 Lozenge Box
PRINCIPAL DISPLAY PANEL - 25 Lozenge Box

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130747200612427GTIN-13: 0747200612427
EAN-13: 0747200612427
GTIN-12: 747200612427
UPC-A: 747200612427
GTIN storage (14 digits): 00747200612427		cold-eeze-01.jpg

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
73598-1242-12025-12-16C16284748780-11030e365-0cf2-111a-e063-dadaa90a10e2Cold Eeze ®
73598-1242-12024-01-30C16284748780-11030e365-0cf2-111a-e063-dadaa90a10e2Cold Eeze ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1242-1COLD EEZE25 in 1 BOXLOZENGE253

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
73598-124273598-1242-1

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
ZINC GLUCONATEU6WSN5SQ1ZACTIB
CORN SYRUP9G5L16BK6NIACT
GLYCINETE7660XO1CIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD EEZEZINC GLUCONATEJHK Inc dba American Safety & First Aide6e729c0-90ee-410e-b425-9c19e3333a242025-12-16WarningsExact identifier
ndc (package): 73598-1242-1
ndc (product): 73598-1242
ndc11 (package): 73598124201
spl id: d58119e7-3440-4bd5-957c-7d2fc52cf8d3
spl set id: e6e729c0-90ee-410e-b425-9c19e3333a24

Reported adverse events (FAERS/openFDA)#

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