Other
Drug Facts
Zicam Cold Remedy Lozenge
FDA Label NDC 10237-483
10 label sections · Submitted to the FDA by Church & Dwight Co., Inc. · 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 10237-483). 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, warnings, otc - keep out of reach of children, directions, other information, 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.
Warnings
Sore throat warning: If sore through is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
If you are allergic to zinc, consult a doctor before use
Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur, cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
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 drop at the onset of symptoms. Completely dissolve drop in mouth. Do not chew. Do not swallow whole.
- repeat every 2 – 3 hours, not to exceed 7 drops 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
beta carotene, citric acid, corn syrup, flavors, malic acid, menthol, purified water, sucralose, sucrose
Principal Display Panel - 25 Drop Pouch
ZICAM
COLD REMEDY
SHORTENS COLDS
SOOTHES SORE THROATS AND COUGHS+
#1 COLD SHORTENER BRAND*
Honey Lemon Flavor
HOMEOPATHIC
25 DROPS
* Please review the disclaimer below.
