Cold-eeze
FDA Label NDC 61941-0225

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prophase Labs, Inc. for the product Cold-eeze (NDC 61941-0225). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (per tablet), purpose, uses, ask a doctor before use if you, otc - stop use, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Cold-EEZE® Daytime QuickMelts® (AM)

Drug Facts

Cold-EEZE® Nighttime QuickMelts® (PM)

Drug Facts

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

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.

    • 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.

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.

Otc - Stop Use

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

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

Otc - When Using

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.

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.

Otc - Pregnancy Or Breast Feeding

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.
      • 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.
    • 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.

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.

Otc - Purpose

Active ingredients (per tablet)Purpose
Zincum Gluconicum 1XCold Remedy
Valeriana Officinalis 1XSleep Disorder Remedy
Chamomile (Matricaria recutita) 2XRelaxation and Calming

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.

Otc - Do Not Use

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.

Questions Or Comments

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

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)

      Principal Display Panel (Kit Carton)

      Principal Display Panel (Kit Carton)

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