Label: 4 WAY FAST ACTING- phenylephrine hydrochloride spray

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

Drug Label Information

Updated May 13, 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
    • 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.

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

    benzalkonium chloride solution, 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 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
  • 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)  
    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
    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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