COLD-EEZE- zinc gluconate lozenge

Cold-EEZE by

Drug Labeling and Warnings

Cold-EEZE by is a Homeopathic medication manufactured, distributed, or labeled by ProPhase Labs, Inc., Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

Warnings

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

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

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

Diabetic Warning: sugar replacements may affect blood sugar levels.

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

Keep out of reach of children.

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 - 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 - 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 - 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 - 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 - 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

INGREDIENTS AND APPEARANCE

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0081
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Glycine (UNII: TE7660XO1C)
Isomalt (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	CHERRY (Sugar Free Wild Cherry)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0081-1	24 in 1 CASE
1	NDC: 61941-0081-8	18 in 1 PACKAGE
2	NDC: 61941-0081-2	48 in 1 CASE
2	NDC: 61941-0081-8	18 in 1 PACKAGE
3	NDC: 61941-0081-3	144 in 1 CASE
3	NDC: 61941-0081-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2005

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0082
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Glycine (UNII: TE7660XO1C)
Isomalt (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	CHERRY (Sugar Free Wild Cherry)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0082-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2005

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0091
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Glycine (UNII: TE7660XO1C)
Isomalt (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	HONEY (Sugar Free Honey Lemon)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0091-1	24 in 1 CASE
1	NDC: 61941-0091-8	18 in 1 PACKAGE
2	NDC: 61941-0091-2	48 in 1 CASE
2	NDC: 61941-0091-8	18 in 1 PACKAGE
3	NDC: 61941-0091-3	144 in 1 CASE
3	NDC: 61941-0091-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2005

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0092
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Glycine (UNII: TE7660XO1C)
Isomalt (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	HONEY (Sugar Free Honey Lemon)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0092-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2005

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Glycine (UNII: TE7660XO1C)
Isomalt (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	POMEGRANATE (Sugar Free Pomegranate)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0101-1	24 in 1 CASE
1	NDC: 61941-0101-8	18 in 1 PACKAGE
2	NDC: 61941-0101-2	48 in 1 CASE
2	NDC: 61941-0101-8	18 in 1 PACKAGE
3	NDC: 61941-0101-3	144 in 1 CASE
3	NDC: 61941-0101-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2005

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc - UNII:J41CSQ7QDS)	Zinc Gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Glycine (UNII: TE7660XO1C)
Isomalt (UNII: S870P55O2W)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	POMEGRANATE (Sugar Free Pomegranate)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0102-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2005

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL, ANALYSIS

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE, ANALYSIS, PACK, REPACK