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

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

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.

SPL UNCLASSIFIED SECTION

Cold-EEZE® Nighttime QuickMelts® (PM)

Drug Facts

ACTIVE INGREDIENT

• 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)

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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]

Inactive Ingredients
Ingredient Name	Strength
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

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

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

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

Labeler - ProPhase Labs, Inc. (620557298)

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

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