Cold-eeze
FDA Label NDC 61941-0234

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 61941-0234). 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, ask a doctor before use if you, otc - stop use, sore throat warning, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active Ingredients (2 gummies)Purpose
Zincum Gluconicum 1XCold Remedy
Mentha piperita 1XFor temporary relief of cough
Sambucus nigra 2XFor temporary relief of flu symptoms
Eupatorium perfoliatum 2X(cough, congestion and irritated respiratory tract)
Myrrha 2XFor temporary relief of Sore Throat
Glycyrrhiza G. L. (Licorice Root) 2XFor temporary relief of Irritated Throat

Uses

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

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 for more than 7 days or are accompanied by fever, rash or persistent headache

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

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, 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 gummies when you have cold or flu symptoms
  • Adults:
    • Dissolve 2 gummies in mouth. Do not swallow whole. For best results, dissolve in your mouth.
    • Take 2 gummies 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 12 gummies for adults and 8 gummies 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 gummies on an empty stomach to avoid possible minor stomach upset
  • Store in a cool and dry place

Inactive Ingredients

Citric acid, corn syrup, gelatin, glycine, maltodextrin, natural flavors and colors from fruits and vegetables, pectin and sugar (from beets)

Questions Or Comments

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

Principal Display Panel - 36 Gummy Bottle Label

NEW
for
Adults &
Kids 12
& up

Cold-EEZE®
ZINC GLUCONATE GLYCINE

gummies

SHORTENS YOUR COLD,
WORKS FASTER®+

Plus
Multi-Symptom
Relief
Cold & Flu

36
gummies
HOMEOPATHIC

Also Helps Relieve:

  • ✓Cough+
  • ✓Congestion+
  • ✓Sore Throat+

    • NATURAL FLAVOR
    Mixed Fruit

    Principal Display Panel (36 gummy Bottle Label)

    Principal Display Panel (36 gummy Bottle Label)

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