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Drug Facts
Zicam Cold Remedy Lozenge
FDA Label NDC 10237-473
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 Cold Remedy (NDC 10237-473). 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 lozenge), purpose, uses, sore throat warning, 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 Lozenge)
Zincum aceticum 2x
Zincum gluconicum 2x
Purpose
Reduces duration of the common cold and helps relieve nasal congestion
Uses
- reduces duration of the common cold and helps relieve nasal congestion
- soothes sore throats and coughs
Zicam ® Cold Remedy was not formulated to be effective for flu or allergies.
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 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 lozenge at the onset of symptoms. Completely dissolve lozenge in mouth. Do not chew. Do not swallow whole.
- repeat every 2 – 3 hours, not to exceed 7 lozenges 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, flavors, malic acid, purified water, sucralose, sucrose
Principal Display Panel - 25 Lozenge Pouch Carton
ZICAM ®
COLD REMEDY
SHORTENS COLDS
SOOTHES SORE THROATS
AND COUGHS +
GREAT TASTING!
TAKE AT THE FIRST
SIGN OF A COLD
THE
PRE-COLD
®
MEDICINE
SHORTENS COLDS
LOZENGES
Wild Cherry Flavor
HOMEOPATHIC
25
Individually Wrapped
LOZENGES
* Please review the disclaimer below.
