Label: EXTRA STRENGTH NASAL- phenylephrine hydrochloride spray

  • NDC Code(s): 69842-443-30, 69842-443-40
  • Packager: CVS PHARMACY
  • 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 September 13, 2023

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  • Active ingredients

    Phenylephrine Hydrochloride 1.0 %

  • Purpose

    Nasal decongestant

  • Uses

    ▪
    temporarily relieves nasal congestion due to:
    ▪
    common cold
    ▪
    hay fever
    ▪
    upper respiratory allergies (allergic rhinitis)
    ▪
    temporarily relieves sinus congestion and pressure
    ▪
    shrinks swollen membranes so you can breathe more freely
    ▪
    temporarily restores freer breathing through the nose
  • 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
  • When using this product

    ▪
    do not use more than directed
    ▪
    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

  • 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

    ▪
    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
  • Inactive ingredients

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

    Questions

    1-866-467-2748

  • Principal Display

    Compare to the active ingredient in Extra Strength Neo-Synephrine®*

    Extra Strength

    Nasal Spray

    Phenylephrine hydrochloride 1.0 %

    Nasal Decongestant

    NON-DROWSY

    COLD+ALLERGY

    Nasal Congestion RELIEF

    You can use every 4 hours

    Fast Relief Of:

    Sinus Congestion & Pressure

     
    Colds, Allergies

    *This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Extra Strength Neo-Synephrine®.

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

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

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2021 CVS/pharmacy, CVS.com®

    1-800-SHOP CVS V-12431

    CVS Quality Money Back guarantee

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

    Package Label for Extra Strength Nasal Spray

    Extra Strength Nasal Spray

    Package Label for Extra Strength Sinus Relief

    Extra Strength Sinus Relief Cold and Allergy Relief
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NASAL 
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-443
    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:69842-443-301 in 1 CARTON09/21/2020
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:69842-443-401 in 1 CARTON09/21/2020
    230 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 finalpart34109/21/2020
    Labeler - CVS PHARMACY (062312574)
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