Cold-eeze
FDA Label NDC 61941-0111

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 61941-0111). 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 lozenge), purpose, uses, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, 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® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.

  • gluten-free

Active Ingredient (Per Lozenge)

Zincum Gluconicum 2x (13.3mg)

Purpose

Homeopathic Cold Remedy

Uses

  • to reduce the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness

Otc - Ask Doctor

Ask a doctor before use if you

  • are taking monocycline, doxycycline, tetracycline or are on coumadin therapy, 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • adults and children 12 years and over
  • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
  • repeat every 2 - 4 hours as needed until all symptoms subside
  • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
  • children under 12 years of age should consult a health professional prior to use

Other Information

  • avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
  • avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids

Storage And Handling

  • store in a cool dry place after opening

Inactive Ingredients

corn syrup, honey, glycine, lemon oil, natural green tea flavor and sucrose. No artificial colors or preservatives.

Questions? Comments?

CALL 1-800-505-COLD
9am - 5pm Eastern

Principal Display Panel - 18 Lozenge Carton

Shorten your cold!
Get better faster!

Quigley

Homeopathic
Cold-EEZE®

Clinically proven to
reduce the duration
of the common cold

Zinc
Gluconate
Glycine

PHARMACIST
RECOMMENDED•
#1
ACHIEVEMENT
AWARD

18
Cold Remedy
Lozenges

Natural Green Tea
with Honey Flavor
with other natural flavors

Principal Display Panel (18 Lozenge Carton)

Principal Display Panel (18 Lozenge Carton)

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