OXYMETAZOLINE HYDROCHLORIDE by Zydus Pharmaceuticals (USA) Inc.
Dosage form: spray, metered
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: Zydus Pharmaceuticals (USA) Inc.
NDC Code: 68382-418
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Oxymetazoline hydrochloride 0.05%
- Temporarily relieves nasal congestion due to:
■ a cold ■ hay fever ■ upper respiratory allergies
- promotes nasal and sinus drainage
- temporarily relieves sinus congestion and pressure
- helps clear nasal passages; shrinks swollen membranes
Ask a doctor before use if you have
■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes
■ trouble urinating due to an enlarged prostate gland
- 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 occur
- 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.
If swallowed, get medical help or contact a Poison Control Center right away.
- adults and children 6 to under 12 years of age (with adult supervision):
2 or 3 sprays in each nostril not more 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.
Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing 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 pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.
- Store between 20º - 25ºC (68º - 77ºF)
- retain carton for future reference on full labeling
benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycin, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide.
Cadila Healthcare Ltd.
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
Revision Date: 05/31/2011
oxymetazoline hydrochloride spray, metered
|Labeler - Zydus Pharmaceuticals (USA) Inc. (156861945)|
|Registrant - Zydus Pharmaceuticals (USA) Inc. (156861945)|
|Cadila Healthcare Limited||918596198||Analysis, Manufacture|
Medically reviewed on May 25, 2018