Active Ingredient
Active ingredient (per lozenge
)
Zinc Gluconate 2X HPUS† (2.3%) (13.3 mg zinc)
† The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.
Cold-eeze Cold Remedy
FDA Label NDC 71179-340
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vespyr Brands Inc for the product Cold-eeze Cold Remedy (NDC 71179-340). 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, purposes, uses, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Cold remedy
Uses
- reduces the duration of the common cold
- reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
Otc - Do Not Use
Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.
Otc - When Using
When using this product do not take on an empty stomach (to avoid possible minor stomach upset)
Otc - Stop Use
Stop use and ask your doctor if symptoms persist more than 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a healthcare professional 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 one lozenge at the onset of symptoms
• dissolve entire lozenge in mouth
• do not chew
• do not swallow whole
• do not eat or drink for 15 minutes after use
• repeat every 2-4 hours until symptoms subside
| Adults 18 years and over | do not exceed 6 lozenges per day |
| Children 12 to under 18 years | do not exceed 4 lozenges per day |
| Children under 12 years | ask a doctor before use |
Other Information
- store in a cool, dry place after opening
- best if used within 6 months after opening
Inactive Ingredients
corn syrup, honey, glycine, natural flavors, sucrose
Questions?
call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)
Package Label.Principal Display Panel
Cold-EEZE ®
COLD REMEDY
ZINC GLUCONATE HOMEOPATHIC
SHORTENS YOUR COLD ® by 42%*
SOFT CENTER
25 Zinc Lozenges
CLINICALLY TESTED to Shorten Colds
PHARMACIST Recommended
Helps soothe throat
Natural Liquid Honey Lemon Flavor
©2024 Vespyr Brands ®, LLC
Cold-EEZE ® is a registred trademark of Vespyr Brands ®, LLC
Distributed by Vespyr Brands®, LLC
East Windsor, NJ 08520
This product has not been evaluated by the FDA
*A clinical study found the Cold-EEZE formula reduces the duration of the common cold by 42%, when taken at the first sign of symptoms and used as directed.
The double blind placebo controlled study was conducted at the Cleveland Clinic and published in a peer reviewed journal.
* Please review the disclaimer below.
