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 Mylan Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Cold-EEZE® Daytime QuickMelts® (AM)

Drug Facts

Active ingredient (per tablet)

Zincum Gluconicum 1X

Purpose

Cold Remedy

Uses

• 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.

It is insufficient treatment for Influenza or Allergies.

If pregnant or breastfeeding,

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:
  • o Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
  • o Take 1 tablet at the onset of symptoms
  • o Repeat every 2-4 hours as needed until all symptoms subside
  • o Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
  • o 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)

Zincum Gluconicum 1X

Valeriana Officinalis 1X

Chamomile (Matricaria recutita) 2X

Purpose

Cold Remedy

Sleep Disorder Remedy

Relaxation and Calming

Uses

• 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 use:

• if taking loperamide
• while operating a motor vehicle or machinery or consuming alcohol

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.

It is insufficient treatment for Influenza or Allergies.

Allow 6-8 hours for sleep after taking tablet

If pregnant or breastfeeding,

ask a healthcare practitioner before use

Keep out of reach of children.

In case of overdose,

get medical help or contact a poison control center right away.

Directions

• Take Cold-EEZE® Nighttime QuickMelts® at night when you have cold symptoms
• Adults:
  • o Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
  • o Take 1 Nighttime tablet 1 hour before bedtime
  • o Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
  • o 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

Relax & Sleep Natural Nighttime Formula:

• + Chamomile and Valerian to help you relax and fall asleep faster, naturally
• + Shortens your cold, works faster®
• + Natural Herbal Extracts
• + Gluten Free
• + Dissolves quickly in the mouth without water
• + Releases zinc ions in the mouth

Questions or Comments

Call 1-800-505-2653
(M-F: 8AM-5PM ET)
www.ColdEEZE.com

Manufactured for:
Mylan Consumer Healthcare, Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

+THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.

CEZ:329:44:CT:R1

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC: 46017-329-44

#1 Pharmacist Recommended

Cold-EEZE®
ZINC GLUCONATE GLYCINE

SHORTENS YOUR COLD WORKS FASTER®+

DAYTIME
NIGHTTIME

18 QuickMelts®
DAYTIME:

• Shortens your cold, works faster®+
• Non-Drowsy

6 QuickMelts®
NIGHTTIME:

• Shortens your cold, works faster®+
• Fall asleep faster+, naturally
• Non-habit forming

NATURAL FLAVOR
Mixed Berry
Homeopathic QuickMelts®

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: 46017-329

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-329-44	1 in 1 CARTON; Type 0: Not a Combination Product	02/13/2019

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, UNSPECIFIED (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (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)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

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		02/13/2019

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, UNSPECIFIED (UNII: 2S7830E561)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (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)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

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		02/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		02/13/2019

Labeler - Mylan Consumer Healthcare, Inc. (831410522)