Label: EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT- 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 October 4, 2023

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  • Active ingredients

    Phenylephrine Hydrochloride 1.0 %

  • Purpose

    Nasal decongestant

  • Uses

    ▪
    temporarily relieves nasal congestion:
    ▪
    due to common cold
    ▪
    due to hay fever or other upper respiratory allergies (allergic rhinitis)
    ▪
    temporarily relieves stuffy nose.
    ▪
    helps clear nasal passages; shrinks swollen membranes
    ▪
    temporarily restores freer breathing through the nose
    ▪
    helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
  • Warnings

    Do Not Use

    If you have ever had an allergic reaction to this product or any of its ingredients

  • Ask a doctor before use if you have

    ▪
    heart disease
    ▪
    high blood pressure
    ▪
    thyroid disease
    ▪
    diabetes
    ▪
    trouble urinating due to an enlarged prostate gland
    ▪
    difficulty in urination due to enlargement of the prostate gland
  • When using this product

    ▪
    do not exceed recommended dosage
    ▪
    do not use for more than 3 days. Use only as directed.

    Frequent or prolonged use may cause nasal congestion to recur or worsen

    ▪
    temporary discomfort may occur such as burning, stinging, sneezing and increase in nasal discharge
    ▪
    use of this container by more than one person may spread infection
  • Stop use and ask a doctor if

    symptoms persist for more than 3 days.

  • 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

    ▪
    Use only as directed
    ▪
    to spray, squeeze bottle quickly and firmly
    ▪
    adults and children 12 years older: 2 or 3 sprays in each nostril not more often than every 4 hours.
    ▪
    children under 12 years : ask a doctor
  • Other information

    ▪
    store at room temperature
    ▪
    Protect from light.
  • Inactive ingredients

    anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate

    Questions

    1-866-467-2748

  • Principal Display

    LEADER

    NDC 70000-0132-1

    COMPARE TO NEO-SYNEPHRINE® EXTRA STRENGTH active ingredient

    Extra Strength

    Sinus Relief

    Phenylephrine hydrochloride 1.0 %

    Nasal Decongestant

    Fast Relief Of:

    Sinus Congestion & Pressure

     
    Colds, Allergies

    1 FL OZ (30 mL)

    * This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine® Extra Strength.

    IMPORTANT: Keep this carton for future reference on full labeling.

    Do not use if printed seal over cap is torn or missing

    ©2017 Cardinal Health, All Rights Reserved , CARDINAL HEALTH ,the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

    Cardinal Health™

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

    1-800-200-6313

    Essential to care™ since 1979

    * This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine® Extra Strength.

    LEADER Extra Strength Sinus Relief 1 FL OZ
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT 
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0132
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0132-11 in 1 CARTON06/06/2017
    130 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 finalpart34106/06/2017
    Labeler - CARDINAL HEALTH (063997360)
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