12 HOUR NASAL- oxymetazoline hcl spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)

Available from:

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INN (International Name):

OXYMETAZOLINE HYDROCHLORIDE

Composition:

OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL

Administration route:

NASAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Oxymetazoline HCl................ 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

Authorization status:

OTC monograph final

Summary of Product characteristics

12 HOUR NASAL- OXYMETAZOLINE HCL SPRAY
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_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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_ACTIVE INGREDIENT_
Oxymetazoline HCl 0.05%
_PURPOSE_
Oxymetazoline HCl................ 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
_WARNINGS_
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
WHEN USING THIS PRODUCT
DO NOT EXCEED RECOMMENDED DOSAGE
temporary discomfort such as burning, stinging, sneezing or an
increase in nasal discharge may
occur
do not use for more than 3 days. Frequent or prolonged use may cause
nasal congestion to recur or
worsen.
use only as directed
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.
_DIRECTIONS_
to spray, squeeze bottle quickly and firmly
do not tilt head backward while spraying
wipe nozzle clean after use
do not exceed 2 doses in any 24-hour period
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
children under 6 years of age: ask a doctor
_OTHER INFORMATION_ RETAIN CARTON FOR FUTURE REFERENCE ON FULL LABELING STORE BETWEEN 2°-30°C (36°-86°F) STORE BETWEEN 2°-30°C (36°-86°F)
_INACTIVE INGREDIENTS_
benzalkonium chloride 0.01%, edetate disodium, polyethylene glycol
1450, povidone, propylene
glycol, sodium phosphate dibasic, sodium phosphate monobasic, water
SelBr1