AQUA MARIS FAST ACTING DECONGESTANT- xylometazoline hcl spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K)

Available from:

JGL North America LLC

Administration route:

NASAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporarily relieves nasal congestion for up to 10 hours due to cold, hay fever, and upper respiratory allergies. Relieves symptoms of nasal discomfort caused by dryness and sinus pressure. Stop use and ask a doctor if symptoms persist.

Authorization status:

OTC monograph final

Summary of Product characteristics

AQUA MARIS FAST ACTING DECONGESTANT- XYLOMETAZOLINE HCL SPRAY
JGL NORTH AMERICA LLC
_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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AQUA MARIS®
FAST ACTING DECONGESTANT
XYLOMETAZOLINE HCL 0.1%
_DRUG FACTS_
ACTIVE INGREDIENTS
Xylometazoline HCl 0.1%
PURPOSE
Nasal Decongestant
US ES
Temporarily relieves nasal congestion for up to 10 hours due to cold,
hay fever, and upper respiratory
allergies. Relieves symptoms of nasal discomfort caused by dryness and
sinus pressure.
_WARNINGS_
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
high blood pressure
thyroid disease
diabetes
difficulty urinating due to an enlarged prostate gland
IF PREGNANT OR BREASTFEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact Poison Control Center right
away.
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
Wipe nozzle after each use. The use of this dispenser by more than one
person may spread infection
STOP USE AND ASK A DOCTOR IF symptoms persist.
DIRECTIONS
Adults and children 12 years of age or over: 2 or 3 sprays into each
nostril not more often than every
8 to 10 hours
Do not use more than 3 doses in 24 hours
Do not give to children under 12 years of age unless directed by 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 pump all the way down
with a firm even stroke and sniff
deeply. Wipe nozzle clean after use.
OTHER INFORMATION
Store between 68° and 77° F (20° - 25° C)
INACTIVE INGREDIENTS
purified seawater, potassium dihydrogen phosphate
QUESTION OR COMME