Cold-eeze
FDA Label NDC 61941-0226

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prophase Labs, Inc. for the product Cold-eeze (NDC 61941-0226). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® is a combination product formulated to help you to reduce the duration of the common cold and to help relieve Cold and Flu symptoms. It is insufficient treatment for Influenza or Allergies.

Manufactured for and
Distributed by:
ProPhase Labs, Inc.
P.O. Box 1349, Doylestown
PA 18901

Otc - Purpose

Active Ingredient (per tablet)Purpose
Zincum Gluconicum 1XCold Remedy
Sambucus nigra 1X
Eupatorium perfoliatum 1X		For temporary relief of flu symptoms (cough, nasal and chest congestion and irritated respiratory tract)
Mentha Piperita 2XFor temporary relief of cough
Myrrha 2XFor temporary relief of Sore Throat
Glycyrrhiza G. L. (Licorice Root) 3XFor temporary relief of Irritated Throat

Uses

Take one QuickMelt every 2-4 hours per Directions on other side.

  • to reduce the duration of the common cold
  • reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest congestion post nasal drip and/or hoarseness
  • helps for temporary relief of Sore Throat

Warnings

Ask a doctor before use if you

  • are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines

Otc - Stop Use

Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® when you have cold or flu symptoms
  • Adults:
    • Dissolve entire tablet in mouth. Do not chew. Do not swallow whole
    • Take 1 tablet at the onset of symptoms
    • Repeat every 2-4 hours as needed until all symptoms subside
    • Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
    • Recommended daily dose is 6 tablets for adults and 4 tablets for ages 12-17 years
    • For children under 12 years of age, consult a healthcare practitioner before use

Other Information

  • Do not take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® on an empty stomach to avoid possible minor stomach upset
  • Store in a cool and dry place

Inactive Ingredients

beta carotene, crospovidone, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural honey crystals, natural honey lemon flavor, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose, talc.

Questions Or Comments

Call 1-800-505-2653
(M-F: 9AM-5PM EST)

Principal Display Panel - 24 Tablet Blister Pack Carton

NEW QuickMelts®

GREAT
TASTE

Cold-EEZE®

Zinc Gluconate Glycine

COLD REMEDY

Plus Natural
Multi-Symptom Relief

Cold & Flu

  • +Shortens Your Cold, Works Faster™
  • +Helps Relieve:
    • Cough
    • Chest Congestion
    • Sore Throat

      • 24 QuickMelts®
      Homeopathic

      Natural
      Honey Lemon
      Flavor

      Principal Display Panel (24 Tablet Blister Pack Carton)

      Principal Display Panel (24 Tablet Blister Pack Carton)

* Please review the disclaimer below.