Active Ingredients (In Each Lozenge)
Zincum aceticum 2x
Zincum gluconicum 2x
Sambucus nigra (elderberry) 4x
Zicam Lozenge
FDA Label NDC 10237-462
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 10237-462). 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 active ingredients (in each lozenge), purpose, uses, 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
Purpose
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Zincum aceticum 2x
Zincum gluconicum 2x | Reduces duration of the common cold and helps relieve nasal congestion |
| Sambucus nigra (elderberry) 4x | Helps relieve cold symptoms
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. |
Uses
Reduces duration of the common cold and helps relieve nasal congestion
------------------------------------------------------------------------------------------------------
Zicam ® Cold Remedy was not formulated to be effective for flu and allergies.
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Otc - Ask Doctor
If you are allergic or sensitive to zinc, consult a doctor before using.
Otc - Stop Use
Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.
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. Completely dissolve lozenge in mouth. Do not chew. Do now 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)
- avoid freezing and excessive heat
Inactive Ingredients
citric acid, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, malic acid, purified water, soy lecithin, sucralose, sucrose
Questions? Comments?
call 877-942-2626 toll free
www.zicam.com
Principal Display Panel - 25 Individually Wrapped Center Filled Lozenges
NEW!
Plus ELDERBERRY
ZICAM®
COLD REMEDY
PRE-COLD®
FIGHTER
ZINC &
ELDERBERRY
LOZENGE
Elderberry Flavor
HOMEOPATHIC
TAKE AT
THE FIRST SIGN
25 INDIVIDUALLY WRAPPED
CENTER FILLED
LOZENGES
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