FDA.reportPublic FDA data

ADVANCED HOMEOPATHIC COLD-EEZE

Manufacturer
ADVANCED FIRST AID, INC. | Ultra Seal Corporation | Pharmaloz Manufacturing, Inc.
Effective date
2019-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:29

Label at a glance#

ProductADVANCED HOMEOPATHIC COLD-EEZE
Active ingredientZINC GLUCONATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet) - Zincum Gluconicum 2x (13.3mg)

OTC - PURPOSE SECTION

homeopathic cold remedy

INDICATIONS & USAGE SECTION

Uses:

  • reduce the duration of the common cold
  • reduce the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness

WARNINGS SECTION

Warnings:

  • Cold-Eeze lozenges are formulated to reduce the duration of common cold smptoms and may be insufficient treatment for influenza or allergies.

Ask a doctor before use if you:

  • are taking monocycline, tetracycline, doxycycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medications.

Stop use and ask a doctor if:

  • symptoms persist beyond 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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • adults and children 12 years and over
  • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
  • repeat ever 2-4 hours as needed until all symptoms subside
  • completely dissolve lozenge in mouth (do not chew)
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17

OTHER SAFETY INFORMATION

  • to avoid minor stomach upset, do not dissolve lozenge on an empty stomach
  • do not eat or drink for 15 minutes after use
  • store in a cool dry place after opening

INACTIVE INGREDIENT SECTION

Inactive Ingredients: corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold-Eeze 25ct CartonCold-Eeze 25ct CartonCold-Eeze 25ct CartonCold-Eeze 25ct CartonCold-Eeze 25ct CartonCold-Eeze 25ct Carton

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
67060-122-392023-01-30C16284748780-1f386c64a-3b64-0266-e053-dadaa90a7c1aAdvanced Homeopathic Cold-Eeze

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67060-122-01ADVANCED HOMEOPATHIC COLD-EEZE1 in 1 PACKETLOZENGE11
67060-122-39ADVANCED HOMEOPATHIC COLD-EEZE25 in 1 CARTONLOZENGE251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67060-122ADVANCED HOMEOPATHIC COLD-EEZE (ZINCUM GLUCONICUM 2X) LOZENGE [ADVANCED FIRST AID, INC.]1Legacy NDC, 2 package rows20190917_2ce4e01c-25aa-49e8-86de-5112ff53d235.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67060-12267060-122-01, 67060-122-39

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
b2e6a993-e80c-4067-9df9-41984d57a90f2ce4e01c-25aa-49e8-86de-5112ff53d2352019-09-16WarningsExact identifier
spl id: b2e6a993-e80c-4067-9df9-41984d57a90f
spl set id: 2ce4e01c-25aa-49e8-86de-5112ff53d235

Reported adverse events (FAERS/openFDA)#

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