Drug Facts
Zicam Cold Remedy RapidMelts Runny Nose, Apple Cinnamon Flavor
Zicam Tablet
FDA Label NDC 10237-482
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 10237-482). 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 drug facts, active ingredients (in each tablet), purpose, uses, warnings, 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
Active Ingredients (In Each Tablet)
Allium cepa 5x
Zincum aceticum 2x
Zincum gluconicum 1x
Purpose
| Allium cepa 5x | Helps relieve a runny nose¥ |
Zincum aceticum 2x Zincum gluconium 1x | Reduces duration of the common cold and helps relieve nasal congestion |
¥Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Uses
- helps relieve a runny nose¥
- reduces duration of the common cold and helps relieve nasal congestion
Zicam™ Cold Remedy was not formulated to be effective for flu or allergies.
¥Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings
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
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. 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
Other Information
- store between 15-29°C (59-84°F)
Inactive Ingredients
crospovidone, ferric oxide red, flavor, magnesium stearate, mannitol, microcrystalline cellulose, mono-ammonium glycyrrhizinate, silicon dioxide, sodium starch glycolate, stearic acid, sucralose
Questions? Comment?
call 877-942-2626 toll free www.zicam.com
Principal Display Panel
ZICAM™
COLD REMEDY
SHORTENS COLDS
+ RUNNY NOSE
BI-LAYER RAPIDMELTS
APPLE CINNAMON FLAVOR
HOMEOPATHIC MEDICINE
WITH ZINC AND ALLIUM CEPA
20 QUICK DISSOLVE TABLETS
* Please review the disclaimer below.
