FDA.reportPublic FDA data

Aqua Maris Kids

Manufacturer
JGL North America LLC
Effective date
2014-02-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:37:15

Label at a glance#

ProductAqua Maris Kids Fast Acting Decongestant
Active ingredientXYLOMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Indications and 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.

Dosage and administration

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 am...

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Xylometazoline Hydrochloride 0.05%		Purpose
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - WHEN USING SECTION

  • 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

OTC - PURPOSE SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified seawater, potassium dihydrogen phosphate

Question or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76260-107-05

AQUA®
MARIS
KIDS
Fast Acting
Decongestant

xylometazoline HCl 0.0.05%
+ purified seawater

0.33 fl oz
(10 ml)

Carton
Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76260-107-052023-02-24C16284748780-19855e2a2-42e7-60a7-e053-dbdaa90a05bdAQUA MARIS ® xylometazoline HCl 0.05% + purified seawater
76260-107-052019-11-27C16284748780-19855e2a2-42e7-60a7-e053-dbdaa90a05bdAQUA MARIS ® xylometazoline HCl 0.05% + purified seawater

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
XYLOMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTX5S84033NZ2
XYLOMETAZOLINEACTIVE MOIETYWPY40FTH8K2
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL512
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76260-10776260-107-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLOMETAZOLINE HYDROCHLORIDEX5S84033NZACTIB
WATER059QF0KO0RIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51CAPSULE, DELAYED RELEASE PELLETS / ORAL272 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / INTRA-ARTICULAR0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / NASAL680 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS110 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / SUBCUTANEOUS8 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SUSPENSION / ORAL50 mg/5mlExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / INTRAMUSCULAR0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / ORAL287 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION, SOLUTION / INTRAVENOUS1.36 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SPRAY / NASAL3 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SUSPENSION / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51CAPSULE, COATED PELLETS / ORAL272 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51TABLET / ORAL25 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / INTRAVENOUS68 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / OPHTHALMIC0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SYRUP / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION, SOLUTION / INTRAVESICAL29.2 mgExact identifier — unii candidate
19 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f56fdcfe-bb65-2813-e053-2995a90a8ca70c1f137f-2318-4551-9792-d25542e4d9532023-02-24WarningsExact identifier
spl set id: 0c1f137f-2318-4551-9792-d25542e4d953

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.