1. Home
  2. Labeler Index
  3. Church & Dwight Co., Inc.
  4. 10237-475
  5. Label Information: Zicam Cold Remedy Oral Mist

FDA Label for Zicam Cold Remedy Oral Mist

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. SORE THROAT WARNING
    7. OTC - ASK DOCTOR
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS? COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE CARTON

Zicam Cold Remedy Oral Mist Product Label

The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

DISTRIBUTED BY
CHURCH & DWIGHT CO., INC.
EWING, NJ 08628


Active Ingredients



Zincum aceticum 2x
Zincum gluconicum 1x


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



For oral use only


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 - When Using



When using this product avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.


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:
    • spray 4 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
    • repeat every 2 – 3 hours, not to exceed 7 doses 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



benzalkonium chloride, glycerin, flavors, PEG-40 hydrogenated castor oil, purified water, sucralose, xylitol


Questions? Comments?



call 877-942-2626 toll free


Principal Display Panel - 30 Ml Bottle Carton



ZICAM®
COLD REMEDY

SHORTENS COLDS

+ SOOTHES SORE THROATS
AND COUGHS‡

TAKE AT THE FIRST
SIGN OF A COLD

THE
PRE-COLD®
MEDICINE

SEE
WHAT'S
INSIDE!

SHORTENS COLDS

ORAL MIST™

GREAT TASTING

Arctic Mint Flavor

1.0 FL OZ
(30 mL)

HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - zicam 01

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - zicam 01


* Please review the disclaimer below.