Label: 4 WAY FAST ACTING- phenylephrine hydrochloride spray

  • NDC Code(s): 0067-2086-01, 0067-2086-05, 0067-2086-15, 0067-2086-62
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

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

    When using this product

    •
    do not use more than directed
    •
    do not use 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 care 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 of age and over: 2 or 3 sprays in each nostril not more often than every 4 hours
    •
    children under 12 years of age: 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 solution, benzyl alcohol, boric acid, purified water, sodium borate

  • Questions or Comments?

    1-855-221-5428

  • Principal Display

    NDC 0067-2086-01

    4 way
    Fast Acting
    Phenylephrine Hydrochloride 1%

    Nasal Decongestant

    Fast Relief of:

    1.
    Nasal Congestion
    2.
    Swollen Nasal Membranes
    3.
    Sinus Congestion
    4.
    Sinus Pressure

    Nasal Spray

    1 fl oz (29.6 mL)

    DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

    1-855-221-5428

    Trademarks are owned by or licensed to the GSK group of companies.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    ©2020 GSK group of companies or its licensor.

    Made in Japan

    64810SBC1 Front Carton

    4 Way Fast Acting 1fl oz (29.6 ml)
  • INGREDIENTS AND APPEARANCE
    4 WAY  FAST ACTING
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2086
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 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:0067-2086-011 in 1 CARTON01/01/2010
    129.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:0067-2086-051 in 1 CARTON01/01/201010/31/2013
    214.8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:0067-2086-621 in 1 CARTON01/01/201010/31/2013
    318.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    4NDC:0067-2086-151 in 1 CARTON01/01/201001/31/2010
    437 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2010
    Labeler - Haleon US Holdings LLC (079944263)
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