FDA Label for Cold-eeze Gummies Plus Multi-symptom Relief Cold And Flu

View Indications, Usage & Precautions

Cold-eeze Gummies Plus Multi-symptom Relief Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Prophase Labs, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:

* Please review the disclaimer below.