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.

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

STORAGE AND HANDLING

• store in a cool dry place after opening

SPL UNCLASSIFIED SECTION

• gluten-free

Inactive ingredients

corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

Questions or Comments

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

PRINCIPAL DISPLAY PANEL - 18 Cherry Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

18 Cold Remedy
Lozenges

Homeopathic

All Natural
Cherry Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Cherry Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

24 Cold Remedy
Lozenges

Homeopathic

All Natural
Cherry Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 18 Tropical Orange Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

18 Cold Remedy
Lozenges

Homeopathic

All Natural
Tropical Orange Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Tropical Orange Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

24 Cold Remedy
Lozenges

Homeopathic

All Natural
Tropical Orange Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 18 Lemon Lime Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

18 Cold Remedy
Lozenges

Homeopathic

All Natural
Lemon Lime Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Lemon Lime Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

24 Cold Remedy
Lozenges

Homeopathic

All Natural
Lemon Lime Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 18 Strawberries & Cream Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

18 Cold Remedy
Lozenges

Homeopathic

All Natural Strawberries
& Cream Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Strawberries & Cream Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

24 Cold Remedy
Lozenges

Homeopathic

All Natural Strawberries
& Cream Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 18 Mint Frost Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

18 Cold Remedy
Lozenges

Homeopathic

All Natural
Mint Frost Flavor
with other natural flavors

PRINCIPAL DISPLAY PANEL - 24 Mint Frost Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

• + Clinically proven to reduce the
  duration of the common cold ®
• + #1 Pharmacist Recommended
• + Shortens your cold, works fast

OTC Master's Circle
Achievement Award
#1
Pharmacist
Recommended
Brand!
Pharmacy
Times

24 Cold Remedy
Lozenges

Homeopathic

All Natural
Mint Frost Flavor
with other natural flavors

INGREDIENTS AND APPEARANCE

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0011
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0011-1	24 in 1 CASE
1	NDC: 61941-0011-8	18 in 1 PACKAGE
2	NDC: 61941-0011-2	48 in 1 CASE
2	NDC: 61941-0011-8	18 in 1 PACKAGE
3	NDC: 61941-0011-3	144 in 1 CASE
3	NDC: 61941-0011-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		06/07/1994

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0012
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0012-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		06/07/1994

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0031
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	TROPICAL FRUIT PUNCH (Tropical Orange)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0031-1	24 in 1 CASE
1	NDC: 61941-0031-8	18 in 1 PACKAGE
2	NDC: 61941-0031-2	48 in 1 CASE
2	NDC: 61941-0031-8	18 in 1 PACKAGE
3	NDC: 61941-0031-3	144 in 1 CASE
3	NDC: 61941-0031-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2003

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0032
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	TROPICAL FRUIT PUNCH (Tropical Orange)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0032-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2003

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0041
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	LIME (Lemon Lime / Citrus)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0041-1	24 in 1 CASE
1	NDC: 61941-0041-8	18 in 1 PACKAGE
2	NDC: 61941-0041-2	48 in 1 CASE
2	NDC: 61941-0041-8	18 in 1 PACKAGE
3	NDC: 61941-0041-3	144 in 1 CASE
3	NDC: 61941-0041-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2003

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0042
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	LIME (Lemon Lime / Citrus)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0042-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2003

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0051
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	STRAWBERRY (Strawberry & Cream)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0051-1	24 in 1 CASE
1	NDC: 61941-0051-8	18 in 1 PACKAGE
2	NDC: 61941-0051-2	48 in 1 CASE
2	NDC: 61941-0051-8	18 in 1 PACKAGE
3	NDC: 61941-0051-3	144 in 1 CASE
3	NDC: 61941-0051-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2003

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0052
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	STRAWBERRY (Strawberry & Cream)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0052-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2003

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0071
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	MINT (Mint Frost)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0071-1	24 in 1 CASE
1	NDC: 61941-0071-8	18 in 1 PACKAGE
2	NDC: 61941-0071-2	48 in 1 CASE
2	NDC: 61941-0071-8	18 in 1 PACKAGE
3	NDC: 61941-0071-3	144 in 1 CASE
3	NDC: 61941-0071-8	18 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2010

COLD-EEZE 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0072
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
Corn Syrup (UNII: 9G5L16BK6N)
Glycine (UNII: TE7660XO1C)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	MINT (Mint Frost)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0072-4	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2010

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