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Aqua Maris

JGL North America LLC

AQUA MARIS® Fast Acting DecongestantXylometazoline HCl 0.1%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Active ingredients
Xylometazoline HCl 0.1%
Purpose
Nasal Decongestant

Aqua Maris 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

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.

Aqua Maris 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)

Aqua Maris

Aqua Maris

Xylometazoline HCL SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76260-106
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
XYLOMETAZOLINE HYDROCHLORIDE XYLOMETAZOLINE 10 mg

Inactive Ingredients

Ingredient Name Strength
water
POTASSIUM PHOSPHATE, MONOBASIC

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-15


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Be sure to consult your doctor before taking any medication!
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