Aqua Maris Fast Acting Decongestant

Dosage form: spray
Ingredients: XYLOMETAZOLINE HYDROCHLORIDE 10mg in 10mL
Labeler: JGL North America LLC
NDC Code: 76260-106

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®
Fast Acting Decongestant
Xylometazoline HCl 0.1%

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:76260-106
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
XYLOMETAZOLINE HYDROCHLORIDE (XYLOMETAZOLINE) XYLOMETAZOLINE HYDROCHLORIDE10 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POTASSIUM PHOSPHATE, MONOBASIC 
Packaging
#Item CodePackage Description
1NDC:76260-106-301 BOTTLE, SPRAY (BOTTLE) in 1 CARTON
110 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/15/2012
Labeler - JGL North America LLC (968070503)

Revised: 12/2012
 
JGL North America LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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