FDA.reportPublic FDA data

Aqua Maris

Manufacturer
JGL North America LLC
Effective date
2012-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:42:34

Label at a glance#

ProductAqua Maris Fast Acting Decongestant
Active ingredientXYLOMETAZOLINE HYDROCHLORIDE
Label structure13 sections

Indications and 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.

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Xylometazoline HCl 0.1%		Purpose
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty urinating due to an enlarged prostate gland

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist.

Directions

OTC - PURPOSE SECTION

  • 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

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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)

Carton
Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76260-106-302023-02-22C16284748780-19855d018-d4b4-cd31-e053-dbdaa90ab51aAQUA MARIS® Fast Acting Decongestant Xylometazoline HCl 0.1%
76260-106-302019-11-27C16284748780-19855d018-d4b4-cd31-e053-dbdaa90ab51aAQUA MARIS® Fast Acting Decongestant Xylometazoline HCl 0.1%

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
XYLOMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTX5S84033NZ1
XYLOMETAZOLINEACTIVE MOIETYWPY40FTH8K1
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL511
WATERINACTIVE INGREDIENT059QF0KO0R1

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
76260-10676260-106-30

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 PHOSPHATE4J9FJ0HL51INJECTION / SUBCUTANEOUS8 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 PHOSPHATE4J9FJ0HL51SOLUTION / OPHTHALMIC0.2 %w/wExact 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 PHOSPHATE4J9FJ0HL51INJECTION / INTRAMUSCULAR0.3 %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 / INTRA-ARTICULAR0.3 %w/vExact 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 PHOSPHATE4J9FJ0HL51INJECTION, SOLUTION / INTRAVESICAL29.2 mgExact 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 PHOSPHATE4J9FJ0HL51SYRUP / ORAL19 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 PHOSPHATE4J9FJ0HL51CAPSULE, DELAYED RELEASE PELLETS / ORAL272 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 PHOSPHATE4J9FJ0HL51TABLET / ORAL25 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 PHOSPHATE4J9FJ0HL51CAPSULE, COATED PELLETS / ORAL272 mgExact 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 / ORAL287 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
f546cdc7-d34a-9bef-e053-2995a90aa745b70ba985-2894-493f-a4cf-c9102fe36d972023-02-22WarningsExact identifier
spl set id: b70ba985-2894-493f-a4cf-c9102fe36d97

Reported adverse events (FAERS/openFDA)#

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