Label: WAL FOUR- phenylephrine hydrochloride 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 March 2, 2021

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  • Active ingredient

    Phenylephrine hydrochloride 1%

  • Purpose

    Nasal decongestant

  • Uses

    •
    temporarily relieves nasal congestion due to:
    •
    common cold
    •
    hay fever
    •
    upper respiratory allergies
  • Warnings

    Ask a doctor before use if you have

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

    When using this product

    •
    do not use more than directed
    •
    do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
    •
    use only as directed
    •
    temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
    •
    use of this container by more than one person may spread infection

    Stop use and ask a doctor if

    symptoms persist

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    •
    adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
    •
    children under 12 years: ask a doctor

    Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

  • Other information

    •
    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to 4-Way® Nasal Spray active ingredient

    Wal-Four®

    Nasal Spray

    PHENYLEPHRINE HYDROCHLORIDE 1% / NASAL DECONGESTANT

    For fast relief of nasal congestion, swollen nasal membranes, sinus congestion & sinus pressure.

    1 FL OZ (29.6 mL)

    648-94-wal-four nasal spray.jpg
  • INGREDIENTS AND APPEARANCE
    WAL FOUR 
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0648
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0648-101 in 1 CARTON09/20/2002
    129.6 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/20/2002
    Labeler - Walgreen Company (008965063)
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