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Drug Facts
DISTRIBUTED BY CHURCH & DWIGHT CO., INC.
EWING, NJ 08628
Zicam Tablet
FDA Label NDC 10237-477
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 10237-477). 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, otc - purpose, uses, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Echinacea angustifolia 5x | Helps relieve stuffy nose Claims based on traditional homeopathic practice, not accepted medical evidence. |
| Zincum aceticum 2x Zincum gluconicum 1x | 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 was not formulated to be effective for flu or allergies.
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 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
ascorbic acid, crospovidone, FD&C yellow no. 5 aluminum lake (tartrazine), flavor, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose
Questions? Comments?
call 877-942-2626 toll free
Principal Display Panel - 25 Tablet Bottle Carton
SHORTENS COLDS
ZINC
FORMULA!
RAPIDMELTS®
25
Quick Dissolve
TABLETS
Lemon-Lime Flavor
PLUS ECHINACEA
HOMEOPATHIC
Principal Display Panel (25 Tablet Bottle Carton)
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