AQUA MARIS FAST ACTING DECONGESTANT- xylometazoline hcl spray

Aqua Maris by

Drug Labeling and Warnings

Aqua Maris by is a Otc medication manufactured, distributed, or labeled by JGL North America LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients Xylometazoline HCl 0.1%: Purpose ; Nasal Decongestant

Uses

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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.

DOSAGE & ADMINISTRATION

Other information

Store between 68° and 77° F (20° - 25° C)

Inactive Ingredients

purified seawater, potassium dihydrogen phosphate

Question or comments?

1-888-353-AQUA

PRINCIPAL DISPLAY PANEL

NASAL DECONGESTANT

AQUA®
MARIS
Fast Acting
Decongestant

Xylometazoline HCl 0.1%

xylometazoline HCl 0.1%
+ purified seawater

0.33 fl oz (10 ml)

INGREDIENTS AND APPEARANCE

AQUA MARIS  FAST ACTING DECONGESTANT
xylometazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76260-106
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K)	XYLOMETAZOLINE HYDROCHLORIDE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76260-106-30	1 in 1 CARTON
1		10 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/15/2012

Labeler - JGL North America LLC (968070503)