FDA.reportPublic FDA data

First Aid Direct Cold-EEZE Cold Remedy

Manufacturer
Cintas Corporation | Pharmaloz Manufacturing, Inc.
Effective date
2025-09-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:35:07

Label at a glance#

ProductFirst Aid Direct Cold-EEZE Cold Remedy
Active ingredientZINC GLUCONATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per lozenge)

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

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

OTC - PURPOSE SECTION

Purpose

Cold remedy

INDICATIONS & USAGE SECTION

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

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. 

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 to under 18 years: do not exceed 4 lozenges per day
  • Children under 12 years: ask a doctor before use

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn syrup, glycine, natural flavors, sucrose

OTC - QUESTIONS SECTION

Questions?

1-800-327-2704 m-F 8am-5pm EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold-EEZE®

Cold Remedy Lozenge

Zinc Gluconate Homeeopathic

NATURAL CHERRY FLAVOR

Formulated to reduce the duration of the common cold when taken at the first sign of symptoms.

20 Lozenges per box

PDPPDP

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
42961-105-01First Aid Direct Cold-EEZE Cold Remedy1 in 1 PACKETLOZENGE15
42961-105-02First Aid Direct Cold-EEZE Cold Remedy20 in 1 PACKAGELOZENGE205

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
42961-10542961-105-01, 42961-105-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC GLUCONATEU6WSN5SQ1ZACTIB
CORN SYRUP9G5L16BK6NIACT
GLYCINETE7660XO1CIACT
SUCROSEC151H8M554IACT
CHERRYBUC5I9595WIACT

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
First Aid Direct Cold-EEZE Cold RemedyZINC GLUCONATECintas Corporationa6c5906d-8f04-42f7-885f-e7490ec6b5bc2025-09-23WarningsExact identifier
ndc (package): 42961-105-01
ndc (package): 42961-105-02
ndc (product): 42961-105
ndc11 (package): 42961010501
ndc11 (package): 42961010502
spl id: 46d09884-a4a0-4e88-b9f5-41b10ea8d79d
spl set id: a6c5906d-8f04-42f7-885f-e7490ec6b5bc

Reported adverse events (FAERS/openFDA)#

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