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DRUG FACTS
Zicam Cold Remedy Rapidmelts Original
Zicam Kit
FDA Label NDC 10237-480
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Zicam (NDC 10237-480). 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 other, active ingredients (in each tablet), purpose, uses, warnings, otc - ask doctor, 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
Active Ingredients (In Each Tablet)
Zincum aceticum 2x
Zincum gluconicum 1x
Chamomilla 5x
Zincum aceticum 2x
Zincum gluconicum 1x
Purpose
Reduces duration of the common cold and helps relieve nasal congestion
Relieves occasional sleeplessness
Reduces duration of the common cold and helps relieve nasal congestion
Uses
Reduces duration of the common cold and helps relieve nasal congestion
Zicam Cold Remedy ws not formulated to be effective for flu or allergies.
Relieves occasional sleeplessness
Reduces duration of the common cold and helps relieve nasal congestion
Zicam Cold Remedy was not formulated to be effective for flu or allergies.
Warnings
Warnings
Warnings
Otc - Ask Doctor
If you are allergic or sensitive to zinc, consult a doctor before using
If you are allergic or sensitive to zinc, consult a doctor before using
Otc - Stop Use
Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur
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.
If pregnant or breast-feeding, ask a health 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- for best results, use at the first sign of a cold and continue to use until symptoms completely subside
- adults and children 12 years of age and older:
- take 1 tablet at the onset of symptoms
- dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
- repeat every 2–3 hours, not to exceed 7 tablets in 24 hours. Take until symptoms are gone.
- 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 12 years of age: ask a doctor before use
- for best results, use at the first sign of a cold and continue to use until symptoms completely subside
- adults and children 12 years of age and older:
- take 1 tablet at the onset of symptoms
- dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
- repeat every 2–3 hours, not to exceed 7 tablets in 24 hours. Take until symptoms are gone.
- 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 12 years of age: ask a doctor before use
DO NOT TAKE ORIGINAL AND NIGHTTIME RAPIDMELTS AT THE SAME TIME, DO NOT TAKE MORE THAN A TOTAL OF ANY 7 RAPIDMELTS IN A 24-HOUR PERIOD. TAKE ONLY AS DIRECTED.
DO NOT TAKE ORIGINAL AND NIGHTTIME RAPIDMELTS AT THE SAME TIME, DO NOT TAKE MORE THAN A TOTAL OF ANY 7 RAPIDMELTS IN A 24-HOUR PERIOD. TAKE ONLY AS DIRECTED.
Other Information
- store between 15-29°C (59-84°F)
- KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
- store between 15-29°C (59-84°F)
- KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION.
Inactive Ingredients
ascorbic acid, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, natural and artificial flavor, sodium starch glycolate, stearic acid, sucralose
citric acid, crospovidone, D&C red no. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, flavor, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose
Questions? Comments? Side Effects?
call 877-942-2626 toll free
www.zicam.com
Drug Facts
Zicam Cold Remedy Rapidmelts Nighttime
Otc - Questions
Questions? Comments? Side Effects?
call 877-942-2626 toll free
www.zicam.com
Principal Display Panel
ZICAM COLD REMEDY RAPIDMELTS
SHORTENS COLDS
#1 COLD SHORTENER BRAND
ORIGINAL RAPIDMELTS ZINC FORMULA
Citrus Flavor
20 QUICK DISSOLVE TABLETS
HOMEOPATHIC
NIGHTTIME RAPIDMELTS ZINC FORMULA
with Chamomilla for occasional sleeplessness
Concord Grape Flavor
5 QUICK DISSOLVE TABLETS
HOMEOPATHIC
25 TABLETS TOTAL
* Please review the disclaimer below.
