FDA Label for Cold-eeze

View Indications, Usage & Precautions

Cold-eeze 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

COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.


Active Ingredient (Per Lozenge)



Zincum Gluconicum 2x (13.3mg)


Purpose



Cold Remedy


Uses



  • to reduce the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness

Otc - Ask Doctor



Ask a doctor before use if you

  • are taking minocycline, doxycycline, tetracycline or are on coumadin therapy,
    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.


Warnings



Diabetic Warning: sugar replacements may affect blood sugar levels.


Otc - Pregnancy Or Breast Feeding



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


Directions



  • adults and children 12 years and over
  • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
  • repeat every 2 - 4 hours as needed until all symptoms subside
  • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
  • children under 12 years of age should consult a health professional prior to use

Other Information



  • avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
  • avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids
  • store in a cool dry place after opening
  • gluten-free
  • product may produce a laxative effect

Inactive Ingredients



Acesulfame-K, glycine, Isomalt, natural flavors. No artificial colors or preservatives.


Questions Or Comments:



Call 1-800-505-COLD
(9AM-5PM EST)


Principal Display Panel - 18 Lozenge Wild Cherry Carton



GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

Principal Display Panel - 24 Lozenge Wild Cherry Carton



GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

Principal Display Panel - 18 Lozenge Honey Lemon Carton



GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

Principal Display Panel - 24 Lozenge Honey Lemon Carton



GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

Principal Display Panel - 18 Lozenge Pomegranate Carton



GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

Principal Display Panel - 24 Lozenge Pomegranate Carton



GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle
Achievement Award

#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

* Please review the disclaimer below.