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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Sudafed Om Sinus Severe No Drip Nasal Mist With Cooling Menthol (NDC 50580-368). 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 ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Oxymetazoline hydrochloride 0.05%
Nasal decongestant
■ temporarily relieves nasal congestion due to:
■ temporarily relieves sinus congestion and pressure
■ shrinks swollen nasal membranes so you can breathe more freely
Warnings
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 (1-800-222-1222).
To Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.
benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Secure cap after use
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