Active Ingredients (In Each Medicated Drop)
Zincum aceticum 2x
Zincum gluconicum 2x
Zicam Cold Remedy Medicated Fruit Drops - Assorted Fruit Bar, Chewable
FDA Label NDC 10237-468
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 Medicated Fruit Drops - Assorted Fruit (NDC 10237-468). 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 medicated drop), 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
Purpose
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 one medicated drop at onset of symptoms
- chew slowly and dissolve completely before swallowing
- repeat every 2 – 3 hours, not to exceed 5 medicated 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
citric acid, corn syrup, D&C Yellow #10, dextrose, dicalcium phosphate, disodium phosphate, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, malic acid, menthol, natural flavors, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose
Questions? Comments?
Call 877-942-2626 toll free. www.zicam.com
Principal Display Panel - 25 Drop Bottle Label
ZICAM ®
COLD REMEDY
SHORTENS COLDS
TAKE AT THE FIRST
SIGN OF A COLD
THE
PRE-COLD
®
MEDICINE
MEDICATED
FRUIT DROPS
ASSORTED FRUIT FLAVORS
25 DROPS • HOMEOPATHIC
Zicassrtfrtmfd25ctlbl.jpg (Zicassrtfrtmfd25ctlbl)
* Please review the disclaimer below.
