Cold-eeze
FDA Label NDC 61941-0114

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 61941-0114). 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, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, 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 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

  • +Shortens your cold, works faster®
  • +Also helps relieve:
    • ✓Cough
    • ✓Congestion
    • ✓Sore Throat

      • 12
      Cold Remedy
      Lozenges

      Homeopathic

      Actual size

      All Natural
      Mixed Berry Flavor

      Principal Display Panel (12 Lozenge Package)

      Principal Display Panel (12 Lozenge Package)

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