Otc - Active Ingredient
Active ingredients (in each soft chew)
Zincum aceticum 2X
Zincum gluconicum 1X
Caffeinum 5X
Zicam Cold Remedy Soft Chews
FDA Label NDC 52642-232
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 Cold Remedy Soft Chews (NDC 52642-232). 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 - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Reduces duration and severity of the common cold
Helps restore mental alertness
Indications & Usage
Uses
- reduces duration of the common cold
- reduces severity of cold symptoms: sore throat, stuffy nose, sneezing, coughing, nasal congestion
- helps restore mental alertness when experiencing fatigue or drowsiness
Warnings
Zicam Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.
Otc - Ask Doctor
Ask a doctor before use if you have a sensitivity to zinc or are 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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 to use until symptoms completely subside
- adults and children 12 years of age and older:
- take 2 soft chews at the onset of symptoms
- chew thoroughly before swallowing
- repeat every 2-6 hours, not to exceed 4 doses in 24 hours. Take until symptoms are gone.
- to avoid minor stomach upset, do not take on any 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 12 years of age: ask a doctor before use.
Other Safety Information
Other information
- store between 15-29C (59-84F)
Inactive Ingredient
Inactive ingredients
cocoa powder, coconut oil, corn syrup, corn syrup solids, glycerin, natural and artificial flavors, purified water, soy lecithin, sucralose, sucrose
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