Cold-EEZE

Manufacturer
Mylan Consumer Healthcare, Inc.
Effective date
2018-01-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:38:57

Label at a glance#

ProductCold-EEZE Daytime and Nighttime QuickMelts
Active ingredientZinc Gluconate, VALERIAN, Chamomile
Label structure23 sections

Indications and 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

Dosage and administration

• 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 ...

Label contents#

Full prescribing information#

 

SPL UNCLASSIFIED SECTION

Cold-EEZE® Daytime QuickMelts® (AM)

Drug Facts

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Zincum Gluconicum 1X

Purpose

OTC - PURPOSE SECTION

Cold Remedy

Uses

INDICATIONS & USAGE SECTION

  • 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

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare practitioner before use

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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)

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Zincum Gluconicum 1X

Valeriana Officinalis 1X

Chamomile (Matricaria recutita) 2X

Purpose

OTC - PURPOSE SECTION

Cold Remedy

Sleep Disorder Remedy

Relaxation and Calming

Uses

INDICATIONS & USAGE SECTION

  • 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

Ask a doctor before using Cold-EEZE®

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare practitioner before use

In case of overdose,

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Quick Melt Carton

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46017-32946017-329-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4b94e41d-a0b8-434c-bf82-6190d05bad1fd9000fc3-6d0b-4bb9-aa22-2427e6e4307c2018-01-04WarningsExact identifier
spl id: 4b94e41d-a0b8-434c-bf82-6190d05bad1f
spl set id: d9000fc3-6d0b-4bb9-aa22-2427e6e4307c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.