Cold-eeze
FDA Label NDC 50090-4156

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Cold-eeze (NDC 50090-4156). 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 active ingredient (per lozenge), purpose, uses, warnings, if pregnant or breastfeeding,, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Lozenge)

Zincum Gluconicum 2x 

Purpose

Cold Remedy

Uses

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

Warnings

Ask a doctor before use if you

  • are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the absorption of these medicines

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

    Cold-EEZE® lozenges are formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.

If Pregnant Or Breastfeeding,

ask a healthcare practitioner before use. 

Directions

Adults and children 12 years and over:

  • take Cold-EEZE® when you have cold symptoms
  • completely dissolve a Cold-EEZE® lozenge in mouth (do not chew)
  • repeat every 2 - 4 hours as needed until all symptoms subside
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12 - 17

    • Children under 12 years of age should consult a healthcare practitioner prior to use

Other Information

  • do not take Cold-EEZE® lozenges on an empty stomach to avoid possible minor stomach upset
  • do not eat or drink for 15 minutes after use
  • store in a cool, dry place after opening; best if used within 6 months after opening
  • gluten free

Inactive Ingredients

Corn syrup, glycine, natural flavors and sucrose.

No artificial colors or preservatives.

Questions Or Comments:

Call 1-800-505-2653
(M-F: 8AM-5PM ET)

Mylan.com

Manufactured for:
Mylan Consumer Healthcare, Inc.
Morgantown, WV 26505 U.S.A.

+THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

This product has no expiration date.

How Supplied

Product: 50090-4156

NDC: 50090-4156-0 18 LOZENGE in a BAG / 1 in a BOX

* Please review the disclaimer below.