Label: 4 WAY FAST ACTING- phenylephrine hydrochloride spray

  • NDC Code(s): 0067-2086-01, 0067-2086-05, 0067-2086-15, 0067-2086-62
  • Packager: Novartis Consumer Health, Inc.
  • 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 June 23, 2014

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
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  • 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

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  • Stop use and ask a doctor if

    symptoms persist

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  • If pregnant or breast-feeding

    ask a health professional before use.

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  • 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

    1-800-452-0051

    Additional information listed on other panels

    DO NOT USE IF PERFORATED OVERWRAP PRINTED WITH NOVARTIS
    LOGO AROUND THE CAP OR BOTTLE IS BROKEN OR MISSING

    Distributed By: Novartis Consumer Health, Inc.
    Parsippany, NJ 07054-0622

    Made in Canada

    www.4wayspray.com

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  • Principal Display

    NDC 0067-2086-01

    4 Way®
    Fast Acting
    Phenylephrine Hydrochloride 1%

    Nasal Decongestant

    Nasal Spray

    Fast Relief of:

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

    1 fl. oz. (29.6 mL)

    4 Way FAC 1 oz. Carton

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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
    1 29.6 mL in 1 BOTTLE, SPRAY
    2 NDC:0067-2086-05 1 in 1 CARTON
    2 14.8 mL in 1 BOTTLE, SPRAY
    3 NDC:0067-2086-62 1 in 1 CARTON
    3 18.5 mL in 1 BOTTLE, SPRAY
    4 NDC:0067-2086-15 1 in 1 CARTON
    4 37 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/2010
    Labeler - Novartis Consumer Health, Inc. (879821635)
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