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

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

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - ASK DOCTOR
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS
    12. PRINCIPAL DISPLAY PANEL - 12 LOZENGE PACKAGE

Cold-eeze Plus Natural 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 Natural Multi-Symptom Relief Cold & Flu Lozenge is a combination product formulated to help you to reduce the duration of the common cold and to help relieve Cold and Flu symptoms. It is insufficient treatment for Influenza or Allergies.

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


Otc - Purpose



Active Ingredient (per lozenge)    Purpose
Zincum Gluconicum 2XCold Remedy
Sambucus nigra 2XFor temporary relief of flu symptoms (coughing, nasal congestion and irritated respiratory tract)
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 congestion, post nasal drip and/or hoarseness
  • helps for temporary relief of Sore Throat

Otc - Ask Doctor



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

Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



  • Take Cold-EEZE® Plus Natural Multi-Symptom Relief Cold & Flu Lozenges when you have cold or flu symptoms
  • Adults:
    • Dissolve entire lozenge in mouth. Do not chew. Do not swallow whole
    • Take 1 lozenge 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 lozenges for adults and 4 lozenges 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® Plus Natural Multi-Symptom Relief Cold & Flu Lozenges on an empty stomach to avoid possible minor stomach upset
  • Store in a cool and dry place after opening; best if used within 6 months after opening

Inactive Ingredients



Corn syrup, glycine, menthol, natural colors from beet and berry extracts, natural flavors and sucrose. No artificial colors or preservatives.


Questions Or Comments



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


Principal Display Panel - 12 Lozenge Package



+ SHORTENS YOUR COLD

Cold-EEZE®
Zinc Gluconate Glycine

Plus Natural
Multi-Symptom Relief

COLD & FLU

CLINICALLY PROVEN
INGREDIENT

* Please review the disclaimer below.