MedPath

Medique Cold Eeze

Medique Cold-Eeze

Approved
Approval ID

a2b5f20a-87bf-731f-e053-2995a90a1952

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Unifirst First Aid Corporation

DUNS: 832947092

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

zinc gluconate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47682-478
Product Classification
G
Generic Name
zinc gluconate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (4)

CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
ZINC GLUCONATEActive
Quantity: 2 [hp_X] in 1 1
Code: U6WSN5SQ1Z
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/7/2020

Medique Cold-Eeze Label

Medique®

The # 1 Best Selling Zinc Lozenge Brand

Cold-Eeeze®

Zinc Gluconate

Homeopathic

Pull to Open

Shortens Your Cold

#1 Pharmacist Recommended

25 Lozenges

(actual size)

Natural Cherry Flavor

MDQ

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/7/2020

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/7/2020

Questions or comments?

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/7/2020

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/7/2020

Active ingredient

Zincum Gluconicum 2x HPUS†(13.3mg Zinc)
†The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/7/2020

Purpose

Cold Remedy

WARNINGS SECTION

LOINC: 34071-1Updated: 4/7/2020

Warnings

Do not usefor the treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms.

Ask a doctor or pharmacist before use if you aretaking minocycline, doxycycline, tetracycline, or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

When using this productdo not take on an empty stomach (to avoid possible minor stomach upset).

Stop use and ask a doctor if symptoms persist beyond 7 days.

If pregnant or breast-feeding, ask a healthcare professional before use.

**Keep out of reach of children.**In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/7/2020

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 and children 18 years and over: do not exceed 6 lozenges per day

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

**Children under 12 years:**ask a doctor before use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/7/2020

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/7/2020

Inactive ingredients

corn syrup, glycine, natural flavors, sucrose

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Medique Cold Eeze - FDA Drug Approval Details