Label: 4 WAY FAST ACTING- phenylephrine hydrochloride spray

  • NDC Code(s): 0067-2086-01, 0067-2086-05, 0067-2086-15, 0067-2086-62
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 April 9, 2018

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

  • Active ingredient

    Phenylephrine Hydrochloride 1%

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  • Purpose

    Nasal Decongestant

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  • Uses

    temporarily relieves nasal congestion due to:

    common cold
    hay fever
    upper respiratory allergies
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  • Warnings

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    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
    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
    infection may spread if this container is used by more than one person

    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.

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  • 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.
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  • Other information

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

    benzalkonium chloride solution, boric acid, purified water, sodium borate

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  • Questions or Comments?

    1-855-221-5428

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  • 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 PERFORATED OVERWRAP PRINTED WITH GSK
    LOGO AROUND THE CAP OR BOTTLE 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

    ©2017 GSK group of companies or its licensor.

    13183

    Made in Canada

    13183_4 Way Fast Acting_1 oz.JPG
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  • INGREDIENTS AND APPEARANCE
    4 WAY  FAST ACTING
    phenylephrine hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2086
    Route of Administration NASAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-2086-01 1 in 1 CARTON 01/01/2010
    1 29.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2 NDC:0067-2086-05 1 in 1 CARTON 01/01/2010 10/31/2013
    2 14.8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3 NDC:0067-2086-62 1 in 1 CARTON 01/01/2010 10/31/2013
    3 18.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    4 NDC:0067-2086-15 1 in 1 CARTON 01/01/2010 01/31/2010
    4 37 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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