AQUA MARIS KIDS FAST ACTING DECONGESTANT- xylometazoline hcl spray

Aqua Maris Kids by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

• Active Ingredients Xylometazoline Hydrochloride 0.05%: Purpose ; Nasal Decongestant

Uses

For the temporary relief of nasal congestion due to:

• a cold
• hay fever
• 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 in urination due to enlargement of the prostate gland unless directed by a doctor

When using this product

• Do not use this product more than 3 days
• Use only as directed
• Prolonged use may cause nasal congestion to recur or worsen
• If symptoms persist, consult a doctor.
• 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.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

• Children 6 to under 12 years of age (with adult supervision):
  1- 2 sprays in each nostril not more often than every 8 to 10 hours.
• Children 2 to under 6 years of age (with adult supervision):
  1- 2 sprays in each nostril not more often than every 8 to 10 hours.
• Children under 2 years of age: consult a doctor.
• Use only recommended amount
• Do not exceed 3 doses in any 24-hour period.

Use Instructions: place a small amount in each nostril and inhale well back into the nasal passages.

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

SPL UNCLASSIFIED SECTION

76260-107-05

Distributed by:
JGL North America LLC
New York, NY 10024
www.aquamaris.com

Made in Croatia

jgl

PRINCIPAL DISPLAY PANEL - 10mL spray bottle text

NDC: 76260-107-05

AQUA®
MARIS
KIDS
Fast Acting
Decongestant

xylometazoline HCl 0.0.05%
+ purified seawater

0.33 fl oz
(10 ml)

INGREDIENTS AND APPEARANCE

AQUA MARIS KIDS  FAST ACTING DECONGESTANT
xylometazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76260-107
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K)	XYLOMETAZOLINE HYDROCHLORIDE	.05 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: 76260-107-05	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	09/27/2010

Labeler - JGL North America LLC (968070503)