FDA Label for Nasal Decongestant
View Indications, Usage & Precautions
Nasal Decongestant Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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:• common cold• hay fever• upper respiratory allergies• temporarily relieves sinus congestion and pressure• shrinks swollen nasal membranes so you can breathe more freely
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
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).
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: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime metered 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.
Other Information
• store at 20-25°C (68-77°F)• retain carton for future reference on full labeling
Inactive Ingredients
benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
Questions Or Comments?
1-800-616-2471
Principal Display Panel
Soothing – 12 Hour
NASAL DECONGESTANT Spray
Original
Oxymetazoline hydrochloride 0.05%
Compare to active ingredient of Afrin® No Drip
1 FL. OZ. (30 mL)
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