FDA Label for Topcare Sinus Nasal
View Indications, Usage & Precautions
Topcare Sinus Nasal Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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 HCl 0.05%
Purpose
Nasal decongestant
Uses
temporarily relieves
• nasal congestion due to a cold, hay fever, or other upper respiratory allergies• sinus congestion and pressure
Ask A Doctor Before Use If You Have
• heart disease• thyroid disease• diabetes• high blood pressure• trouble urinating due to an enlarged prostate gland
When Using This Product
• do not exceed recommended dosage• do not use this product 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
Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. Secure cap after use.
adults & children 6 yrs. & older (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 24 hours. |
children 2 to under 6 yrs. | ask a doctor |
children under 2 yrs. | do not use |
Other Information
• store at 20-25°C (68-77°F)
Inactive Ingredients
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
Questions Or Comments?
1-888-423-0139
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COMPARE TO SINEX® SEVERE ACTIVE INGREDIENT
Sinus Nasal Spray SEVERE
NASAL DECONGESTANT
OXYMETAZOLINE HCl 0.05%
WITH MENTHOL
ULTRA FINE MIST
12 HOUR RELIEF
OUR PHARMACISTS RECOMMEND
Sinus Congestion & Pressure
Fast & Powerful Relief
1 FL OZ (30 mL)
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