COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS- zinc gluconate, valerian, and chamomile 
Mylan Consumer Healthcare, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Cold-EEZE®
Daytime/Nighttime QuickMelts®

 

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®

Cold-EEZE Daytime and Nighttime Quick Melt Carton
COLD-EEZE  DAYTIME AND NIGHTTIME QUICKMELTS
zinc gluconate, valerian, and chamomile kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-329
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-329-441 in 1 CARTON; Type 0: Not a Combination Product02/13/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 18 
Part 21 BLISTER PACK
Part 1 of 2
COLD-EEZE  DAYTIME QUICKMELTS
zinc gluconate tablet, orally disintegrating
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Glycine (UNII: TE7660XO1C)  
MALIC ACID (UNII: 817L1N4CKP)  
CROSPOVIDONE (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
ColorPINKScoreno score
ShapeOCTAGON (8 sided)Size15mm
FlavorBERRY (mixed berry) Imprint Code AM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/13/201910/31/2022
Part 2 of 2
COLD-EEZE  NIGHTTIME QUICKMELTS
zinc gluconate, valerian, and chamomile tablet, orally disintegrating
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) Zinc Gluconate1 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]
Chamomile (UNII: FGL3685T2X) (Chamomile - UNII:FGL3685T2X) Chamomile2 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Glycine (UNII: TE7660XO1C)  
MALIC ACID (UNII: 817L1N4CKP)  
CROSPOVIDONE (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
ColorBLUEScoreno score
ShapeOCTAGON (8 sided)Size15mm
FlavorBERRY (mixed berry) Imprint Code PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/13/201910/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/13/201910/31/2022
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 1/2018
 
Mylan Consumer Healthcare, Inc.