Label: AQUA MARIS FAST ACTING DECONGESTANT- xylometazoline hcl spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 1, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    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

    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.

  • 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

  • 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

  • INGREDIENTS AND APPEARANCE
    AQUA MARIS  FAST ACTING DECONGESTANT
    xylometazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76260-106
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K) XYLOMETAZOLINE HYDROCHLORIDE10 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:76260-106-301 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)