Drugplain

Zicam Extreme Congestion Relief .5 mg/mL

oxymetazoline hydrochloride · SPRAY · Church & Dwight Co., Inc.

1 Recall on Record
Plain English

Zicam Extreme Congestion Relief is a spray containing oxymetazoline hydrochloride at .5 mg/mL, taken nasal. Manufactured by Church & Dwight Co., Inc..

Key Facts

Brand Name
Zicam Extreme Congestion Relief
Generic Name
oxymetazoline hydrochloride
NDC Code (Product)
10237-464
Manufacturer
Church & Dwight Co., Inc.
Strength
.5 mg/mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
10/01/2021

Recall History

1 Recall on Record
Class I12/18/2012

Matrixx Initiatives Inc

Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

anosmia109 reports
ageusia64 reports
fatigue48 reports
nausea43 reports
pain41 reports
diarrhoea37 reports
product dose omission issue34 reports
drug ineffective30 reports
pruritus28 reports
dyspnoea27 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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 use pump: 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'

Warnings

Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland 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 Stop use and ask a doctor if symptoms persist If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Zicam Extreme Congestion Relief used for?

Zicam Extreme Congestion Relief contains oxymetazoline hydrochloride. It is a spray taken nasal. Consult your doctor for specific uses.

Is Zicam Extreme Congestion Relief a controlled substance?

Zicam Extreme Congestion Relief is not classified as a controlled substance by the DEA.

What is the generic name for Zicam Extreme Congestion Relief?

The generic name for Zicam Extreme Congestion Relief is oxymetazoline hydrochloride. There are 12 other brand versions of oxymetazoline hydrochloride.

What is the NDC code for Zicam Extreme Congestion Relief .5 mg/mL?

The NDC (National Drug Code) for Zicam Extreme Congestion Relief .5 mg/mL is 10237-464, listed by Church & Dwight Co., Inc..