Cold-EEZE® Daytime QuickMelts® (AM)

Drug Facts

Active ingredient (per tablet)

Zincum Gluconicum 1X

Purpose

Cold Remedy

Uses

Take 1 QuickMelt every 2-4 hours per Directions on inside panel.

to reduce the duration of the common cold.
reduces the severity of cold symptoms: cough, sore throat, nasal congestion post nasal drip and/or hoarseness.

Warnings

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.

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

Cold-EEZE® QuickMelts® Daytime is formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.

If pregnant or breast feeding, ask a healthcare practitioner before use.

Keep out of reach of children.

Directions

Take Cold-EEZE® Daytime QuickMelts® when you have cold symptoms
Adults and Children 12 years and over:
- Dissolve entire tablet in mouth. Do not chew.
  Do not swallow whole.
- Take 1 tablet 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 6 tablets for adults and 4 tablets 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® QuickMelts® on an empty stomach to avoid possible minor stomach upset.
Store in a cool and dry place.

Inactive ingredients

crospovidone, FD&C Red # 40, glycine, magnesium stearate, malic acid, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose, talc.

Cold-EEZE® Nighttime QuickMelts® (PM)

Drug Facts

Active ingredients (per tablet)	Purpose
Zincum Gluconicum 1X	Cold Remedy
Valeriana Officinalis 1X	Sleep Disorder Remedy
Chamomile (Matricaria recutita) 2X	Relaxation and Calming

Uses

Take 1 Nighttime QuickMelt 1 hour before bedtime per Directions on inside panel.

to reduce the duration of the common cold.
reduces the severity of cold symptoms: cough, sore throat, nasal congestion post nasal drip and/or hoarseness.
helps to relax and sleep easier to get rested.

Warnings

Ask a doctor before using Cold-EEZE®

Nighttime QuickMelts® if you

are taking fluvoxamine (Luvox), minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines.
are under medical supervision and/or are taking tranquilizers, sedatives or anti-seizure medicines.
do not take concomitantly with loperamide.

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

Cold-EEZE® Nighttime QuickMelts® is a combination product formulated to help you to sleep easier and to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.

Do not take Cold-EEZE® Nighttime QuickMelts® while operating a motor vehicle or machinery or consuming alcohol.

Allow 6-8 hours for sleep after taking tablet.

If pregnant or breast feeding, ask a healthcare practitioner before use.

Keep out of reach of children.

Directions

Take Cold-EEZE® Nighttime QuickMelts® at night when you have cold symptoms.
Adults;
- Dissolve entire tablet in mouth. Do not chew.
  Do not swallow whole.
- Take 1 Nighttime tablet 1 hour before bedtime.
- Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids.
Recommended dose is 1 tablet for adults.
For individuals under the age of 18, consult a healthcare practitioner before use.

Other information

Do not take Cold-EEZE® QuickMelts® on an empty stomach to avoid possible minor stomach upset.
Store in a cool and dry place.

Inactive ingredients

crospovidone, FD&C Blue #1 & #2, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, sodium lauryl sulfate, silicon dioxide, sodium starch glycolate, stevia, sucralose, talc.

Questions or Comments

Call 1-800-505-2653 (M-F: 9AM-5PM EST)

Manufactured for and
Distributed by:
ProPhase Labs, Inc.
P.O. Box 1349, Doylestown
PA 18901

PRINCIPAL DISPLAY PANEL - Kit Carton

NEW QuickMelts®

GREAT
TASTE

Cold-EEZE®
Zinc Gluconate Glycine
COLD REMEDY

CLINICALLY PROVEN
INGREDIENT

Daytime
Nighttime
#1 Pharmacist Recommended

Daytime

﹢: Shortens your cold,
works faster™
﹢: Non-drowsy

Nighttime

﹢: Shortens your cold,
works faster™
﹢: Fall asleep faster,
naturally
﹢: Non-habit forming

18 MELTS
(Daytime)

QuickMelts®
Natural
Mixed Berry Flavor
Homeopathic

6 MELTS
(Nighttime)

COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS
zinc gluconate, valerian, and chamomile kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61941-0225

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61941-0225-4	1 in 1 CARTON

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BLISTER PACK	18
Part 2	1 BLISTER PACK	6

Part 1 of 2

COLD-EEZE DAYTIME QUICKMELTS
zinc gluconate tablet, orally disintegrating

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	Zinc Gluconate	1 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
Glycine (UNII: TE7660XO1C)
MALIC ACID (UNII: 817L1N4CKP)
Crospovidone (UNII: 68401960MK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK	Score	no score
Shape	OCTAGON (8 sided)	Size	15mm
Flavor	BERRY (MIXED BERRY)	Imprint Code	AM
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved homeopathic		12/01/2014

Part 2 of 2

COLD-EEZE NIGHTTIME QUICKMELTS
zinc gluconate, valerian, and chamomile tablet, orally disintegrating

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	Zinc Gluconate	1 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	1 [hp_X]
Chamomile (UNII: FGL3685T2X) (Chamomile - UNII:FGL3685T2X)	Chamomile	2 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
Glycine (UNII: TE7660XO1C)
MALIC ACID (UNII: 817L1N4CKP)
Crospovidone (UNII: 68401960MK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE	Score	no score
Shape	OCTAGON (8 sided)	Size	15mm
Flavor	BERRY (MIXED BERRY)	Imprint Code	PM
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved homeopathic		12/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved homeopathic		12/01/2014

Labeler - ProPhase Labs, Inc. (620557298)

Name	Address	ID/FEI	Business Operations
Establishment
ProPhase Labs, Inc.		620557298	LABEL(61941-0225) , ANALYSIS(61941-0225) , REPACK(61941-0225)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE(61941-0225) , PACK(61941-0225) , REPACK(61941-0225)

Cold-EEZE® Daytime/Nighttime QuickMelts®

Active ingredient (per tablet)

Purpose

Uses

Warnings

Ask a doctor before use if you

Directions

Other information

Inactive ingredients

Uses

Warnings

Ask a doctor before using Cold-EEZE®

Directions

Other information

Inactive ingredients

Questions or Comments

PRINCIPAL DISPLAY PANEL - Kit Carton

Cold-EEZE®
Daytime/Nighttime QuickMelts®