FDA Label for Nasalub Nasal Relief
View Indications, Usage & Precautions
Nasalub Nasal Relief Product Label
The following document was submitted to the FDA by the labeler of this product Genomma Lab 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.
Otc - Active Ingredient
Active ingredient Purpose
Oxymetazoline HCL 0.05%................................... Nasal decongestant
Otc - Purpose
Uses
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- shrinks swollen nasal membranes so you can breathe more freely
Warnings
Warnings
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 directed. 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 icrease 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 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. To open, rotate cap to align the marks. squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tiliting the head, insert nozzle into nostril. Fully depress rim with a firm, een stroke and sniff deeply. Wipe nozzle clean after each use and sanp cab back onto the bottle.
Storage And Handling
Other information
- store between 20° and 25°C (68° and 77°F)
- retain carton for future reference on full labeling
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, benzyl alcohol, dibasic sodium phospahte hydrate, disodium EDTA, distilled water, monobasic sodium phosphate dihydrate, PEG 1450, PVP K30
Dosage & Administration
DISTRIBUTED BY:
GENOMMA LAB USA INC.
HOUSTON, TX 77027
MADE IN KOREA
Package Label.Principal Display Panel
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