EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [CARDINAL HEALTH]

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EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [CARDINAL HEALTH]
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NDC 70000-0132-1
Set ID 0d8a009c-30b5-4f12-90bd-f8aa1110243f
Category HUMAN OTC DRUG LABEL
Packager CARDINAL HEALTH
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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 (097537435)
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