Cold-eeze
FDA Label NDC 61941-0231

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 61941-0231). 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, otc - purpose, uses, otc - ask doctor, sore throat warning, do not use, otc - stop use, 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

Drug Facts

Cold-EEZE® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® is a combination product formulated to help you to sleep easier, reduce the duration of the common cold and to help for temporary relief of cold and flu symptoms. It is insufficient treatment for Influenza or Allergies.

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

Otc - Purpose

Active ingredient (per tablet)Purpose
Zincum Gluconicum 1XCold Remedy
Eupatorium perfoliatum 1XFor temporary relief of flu symptoms
Sambucus nigra 1X(cough, nasal and chest congestion and irritated respiratory tract)
Valeriana Officinalis 1XSleep Disorder Remedy
Chamomile (Matricaria recutita) 2XRelaxation and Calming
Mentha Piperita 2XFor temporary relief of cough
Myrrha 2XFor temporay relief of Sore Throat
Glycyrrhiza G.L. (Licorice Root) 3XFor temporary relief of Irritated Throat

Uses

  • to reduce the duration of the common cold
  • reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest congestion, post nasal drip and/or hoarseness
  • helps for temporary relief of Sore Throat
  • helps to relax and sleep easier to get rested

Otc - Ask Doctor

Ask a doctor before use 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
  • are under medical supervision for diabetes or have multiple sclerosis (MS), rheumatoid arthritis (RA) or an auto-immune condition

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

Do Not Use

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

Otc - Stop Use

Stop use and ask your healthcare practitioner if symptoms persist for more than 7 days or are accompanied by fever, rash or persistent headache

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare practitioner before use.

Otc - Keep Out Of Reach Of Children

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® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® at night when you have cold or flu symptoms
  • Adults:
    • Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    • Take 1 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
    • Allow 6-8 hours for sleep after taking tablet
    • For individuals under the age of 18, consult a healthcare practitioner before use

Other Information

  • Do not take Cold-EEZE® Plus Nighttime Multi-Symptom Relief Cold & Flu QuickMelts® on an empty stomach to avoid possible minor stomach upset
  • Store in a cool and dry place

Inactive Ingredients

crospovidone, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural color from carrot and hibiscus concentrates, natural flavors, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose

Otc - Questions

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

Principal Display Panel - 18 Tablet Blister Pack Carton

Relax & Sleep!+
#1 Pharmacist Recommended

Cold-EEZE®

ZINC GLUCONATE GLYCINE

SHORTENS YOUR COLD,
WORKS FASTER®+

Plus Nighttime
Multi-Symptom Relief
Cold & Flu

ALSO HELPS RELIEVE:

  • ☑Cough+
  • ☑Sore Throat+
  • ☑Chest Congestion+

    • Fall asleep faster,
    naturally+

    CLINICALLY PROVEN
    INGREDIENT

    18
    QuickMelts®
    HOMEOPATHIC
    (actual
    size)

    NATURAL FLAVOR
    Mixed Berry

    Principal Display Panel (18 Tablet Blister Pack Carton)

    Principal Display Panel (18 Tablet Blister Pack Carton)

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