AQUA MARIS KIDS  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.

----------

AQUA MARIS ®

xylometazoline HCl 0.05% + purified seawater

Drug Facts

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 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.

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

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)

Carton
AQUA MARIS KIDS   FAST ACTING DECONGESTANT
xylometazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76260-107
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K) XYLOMETAZOLINE HYDROCHLORIDE0.05 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76260-107-051 in 1 CARTON09/27/201002/24/2023
110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/27/201002/24/2023
Labeler - JGL North America LLC (968070503)
Establishment
NameAddressID/FEIBusiness Operations
JGL d. d.631240835analysis(76260-107) , manufacture(76260-107) , pack(76260-107)

Revised: 2/2023
Document Id: f56fdcfe-bb65-2813-e053-2995a90a8ca7
Set id: 0c1f137f-2318-4551-9792-d25542e4d953
Version: 3
Effective Time: 20230224
 
JGL North America LLC