FDA Label for Shopko Original Nasal
View Indications, Usage & Precautions
Shopko Original Nasal Product Label
The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. 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.
Otc - Active Ingredient
Active Ingredient Purpose
Oxymetazoline hydrochloride 0.05% ......................................Nasal
decongestant
Otc - Purpose
Uses
- temporarily relieves nasal congestion due to
- common cold
- hay fever
- upper respiratory allergies
- sinusitis
- shrinks swollen nasal membranes so you can breathe more
freely
Warnings
Warnings
For external use only
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Otc - When Using
When using this product
- do not use more than directed
- do not use 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
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before
use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.
Indications & Usage
Directions
- adults and children 6 to 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 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.
Storage And Handling
Other information
- store between 15o and 25oC (59o and 77oF)
- retain carton for future reference on full labeling
Inactive Ingredient
Inactive ingredients: benzalkonium chloride solution, edetate
disodium, polyethylene glycol, sodium phosphate dibasic, sodium phosphate
monobasic, water
Dosage & Administration
Distributed by:
UNITED EXCHANGE CORP.
17211 Valley View Ave.
Cerritos, CA 90703 USA
Made in Korea
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