FDA Label for Zicam Extreme Congestion Relief
View Indications, Usage & Precautions
Zicam Extreme Congestion Relief 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.
Active Ingredient
Oxymetazoline hydrochloride 0.05%
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to:
- the common cold
- hay fever
- upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- helps clear nasal passages
- shrinks swollen membranes
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Otc - When Using
When using this product
- do not use more than directed
- do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
- temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
- use of this container by more than one person may spread infection
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
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. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
- children under 6 years of age: ask a doctor
- to open, hold the actuator to squeeze and turn cap
- hold with thumb at bottom of bottle and nozzle between fingers
- before using the first time, prime pump by depressing several times
- place tip of nozzle just past nasal opening (approximately 1/8")
- pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
- wipe nozzle clean after use
- to close, turn cap until it 'clicks'
To use pump:
Inactive Ingredients
aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water
Questions? Comments?
call 877-942-2626 toll free
www.zicam.com
Principal Display Panel - 15 Ml Bottle Carton
ZICAM®
EXTREME
CONGESTION
RELIEF
OXYMETAZOLINE HCl 0.05%
NASAL DECONGESTANT
12
HOUR
RELIEF
COLDS*ALLERGIES
Fast, Powerful
Congestion
Relief
No-Drip Liquid
®
NASAL SPRAY
Soothing
Aloe Vera
0.50 FL OZ (15 mL)
* Please review the disclaimer below.