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.
Cold-eeze
FDA Label NDC 61941-0102
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 61941-0102). 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, active ingredient (per lozenge), purpose, uses, otc - ask doctor, otc - stop use, warnings, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
+ Clinically proven to reduce the
duration of the common cold ®+ #1 Pharmacist Recommended+ Shortens your cold, works fast
18
Cold Remedy
Lozenges
Homeopathic
All Natural
Wild Cherry Flavor
with other natural flavors
Principal Display Panel (18 Lozenge Wild Cherry Carton)
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
+ Clinically proven to reduce the
duration of the common cold ®+ #1 Pharmacist Recommended+ Shortens your cold, works fast
24
Cold Remedy
Lozenges
Homeopathic
All Natural
Wild Cherry Flavor
with other natural flavors
Principal Display Panel (24 Lozenge Wild Cherry Carton)
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
+ Clinically proven to reduce the
duration of the common cold ®+ #1 Pharmacist Recommended+ Shortens your cold, works fast
18
Cold Remedy
Lozenges
Homeopathic
All Natural
Honey Lemon Flavor
with other natural flavors
Principal Display Panel (18 Lozenge Honey Lemon Carton)
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
+ Clinically proven to reduce the
duration of the common cold ®+ #1 Pharmacist Recommended+ Shortens your cold, works fast
24
Cold Remedy
Lozenges
Homeopathic
All Natural
Honey Lemon Flavor
with other natural flavors
Principal Display Panel (24 Lozenge Honey Lemon Carton)
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
+ Clinically proven to reduce the
duration of the common cold ®+ #1 Pharmacist Recommended+ Shortens your cold, works fast
18
Cold Remedy
Lozenges
Homeopathic
All Natural
Pomegranate Flavor
with other natural flavors
Principal Display Panel (18 Lozenge Pomegranate Carton)
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
+ Clinically proven to reduce the
duration of the common cold ®+ #1 Pharmacist Recommended+ Shortens your cold, works fast
24
Cold Remedy
Lozenges
Homeopathic
All Natural
Pomegranate Flavor
with other natural flavors
Principal Display Panel (24 Lozenge Pomegranate Carton)
* Please review the disclaimer below.
