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  5. Label Information: Cold-eeze Plus Nighttime Multi-symptom Relief

FDA Label for Cold-eeze Plus Nighttime Multi-symptom Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - ASK DOCTOR
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTC - QUESTIONS
    14. PRINCIPAL DISPLAY PANEL - 18 TABLET BLISTER PACK CARTON

Cold-eeze Plus Nighttime Multi-symptom Relief Product Label

The following document was submitted to the FDA by the labeler of this product Prophase Labs, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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