FDA Label for Cold-eeze Cold Remedy
View Indications, Usage & Precautions
Cold-eeze Cold Remedy Product Label
The following document was submitted to the FDA by the labeler of this product Vespyr Brands 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.
Active Ingredients
Active ingredients (per lozenge
) . . . . . . . . . . . . . . . . . . . . . .
Purposes
Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc).................... Cold Remedy
Sambucus Nigra 2X HPUS† (1.0%) ........................................... Relieves cough, nasal congestion and irritated respiratory tract*
Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)......................... Relieves irritated throat*
† The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.
Purposes
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
- temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with cold and flu*
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 provide relief of cold and flu symptoms.
Otc - Ask Doctor
Ask a doctor before use if you have
• diabetes • multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition
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 • do not chew
• dissolve entire lozenge in mouth • 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, glycine, natural colors, natural flavors, sucrose
Questions?
call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)
Package Label.Principal Display Panel
Cold-EEZE ®
COLD REMEDY
HOMEOPATHIC
Plus COLD & FLU SYMPTOM RELIEF*
HELPS RELIEVE Cough, Congestion, Sore Throat*
NATURAL MIXED BERRY FLAVOR
25 Lozenges
©2022 Vespyr Brands ®, Inc.
Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.
Distributed by Vespyr Brands®, Inc.
East Windsor, NJ 08520
This product has not been evaluated by the FDA
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
* Please review the disclaimer below.