Aqua Maris Fast Acting Decongestant: Package Insert and Label Information

AQUA MARIS FAST ACTING DECONGESTANT- xylometazoline hydrochloride 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.

Drug Facts

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

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 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 FAST ACTING DECONGESTANT xylometazoline hcl spray

Product Information Product Type HUMAN OTC DRUG 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) XYLOMETAZOLINE HYDROCHLORIDE 10 mg in 10 mL

Inactive Ingredients Ingredient Name Strength WATER POTASSIUM PHOSPHATE, MONOBASIC

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76260-106-30 1 BOTTLE, SPRAY (BOTTLE) in 1 CARTON contains a BOTTLE, SPRAY 1 10 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (76260-106-30)

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)

Revised: 12/2012 JGL North America LLC