FDA Label for Oxymetazoline Hydrochloride
View Indications, Usage & Precautions
Oxymetazoline Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Zydus Pharmaceuticals (usa) 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:
- promotes nasal and sinus drainage
- temporarily relieves sinus congestion and pressure
- helps clear nasal passages; shrinks swollen membranes
■ a cold ■ hay fever ■ upper respiratory allergies
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 occur
- use of this container by more than one person may spread infection
Other
Stop use and ask a doctor if symptoms persist.
If pregnant or breast-feeding, ask a health professional before use.
Manufactured by:
Cadila Healthcare Ltd.
Ahmedabad, India
Distributed by:
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
Rev.: 05/11
Revision Date: 05/31/2011
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):
- children under 6 years of age: ask a doctor.
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.
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.
Other Information
- Store between 20° - 25°C (68° - 77°F)
- retain carton for future reference on full labeling
Inactive Ingredients
benzalkonium chloride solution, camphor, edetate disodium, eucalyptol, glycin, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide.
Container And Carton Labels
NDC 68382-418-07
Oxymetazoline Hydrochloride Concentrated Vapor Nasal Spray, ¾ FL OZ (22 mL)
Rx only
Zydus
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