Otc - Active Ingredient
Active Ingredient (in each tablet) - Zincum Gluconicum 2x (13.3mg)
Advanced Homeopathic Cold-eeze
FDA Label NDC 67060-122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Advanced Homeopathic Cold-eeze (NDC 67060-122). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
homeopathic cold remedy
Indications & Usage
Uses:
- reduce the duration of the common cold
- reduce the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness
Warnings
Warnings:
- Cold-Eeze lozenges are formulated to reduce the duration of common cold smptoms and may be insufficient treatment for influenza or allergies.
- are taking monocycline, tetracycline, doxycycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medications.
- symptoms persist beyond 7 days
Ask a doctor before use if you:
Stop use and ask a doctor if:
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a healthcare professional before use.
Dosage & Administration
Directions:
- adults and children 12 years and over
- for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
- repeat ever 2-4 hours as needed until all symptoms subside
- completely dissolve lozenge in mouth (do not chew)
- recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
Other Safety Information
- to avoid minor stomach upset, do not dissolve lozenge on an empty stomach
- do not eat or drink for 15 minutes after use
- store in a cool dry place after opening
Inactive Ingredient
Inactive Ingredients: corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.
Package Label.Principal Display Panel
Cold-eeze 25ct Carton (Avd1staid Cold Eeze1225 8 6 19)
Cold-eeze 25ct Carton (Avd1staid Cold Eeze1225 8 6 19)
Cold-eeze 25ct Carton (Avd1staid Cold Eeze1225 8 6 19)
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