Otc - Active Ingredient
Active ingredients (in each soft chew)
Zincum aceticum 2X
Zincum gluconicum 2X
Zicam Kids Cold Relief Remedy
FDA Label NDC 52642-231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bestco Inc. for the product Zicam Kids Cold Relief Remedy (NDC 52642-231). 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 - ask doctor, otc - stop use, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Relieves cold symptoms
Indications & Usage
Uses
- temporarily relieves symptoms of the common cold
- nasal congestion
- runny nose
- scratchy throat
Warnings
Zicam Cold Remedy Relief KIDS was formulated to relieve symptoms of the common cold and was not formulated to be effective for flu or allergies.
Otc - Ask Doctor
Ask a doctor before use if your child has a sensitivity to zinc or is allergic to zinc.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- for best results, use at the first sign of a cold and continue to use until symptoms completely subside
- children 6-11 years of age (with adult supervision)
- take 1 soft chew at the onset of symptoms
- chew thoroughly before swallowing
- repeat every 3 hours; not to exceed more than 4 doses in 24 hours
- to avoid minor stomach upset, do not take on an empty stomach
- do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
- children under 6 years of age; do not use.
Other Safety Information
Other information
- store between 15-29C (59-84F)
- avoid freezing and excessive heat
Inactive Ingredient
Inactive ingredients
citric acid, corn syrup, corn syrup solids, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, hydrogenated coconut oil, malic acid, purified water, soy lecithin, sucralose, sucrose
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