Label: NEO-SYNEPHRINE EXTRA STRENGTH- phenylephrine hydrochloride spray

  • NDC Code(s): 69536-175-15, 69536-175-21
  • Packager: Foundation Consumer Healthcare LLC
  • 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 11, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Phenylephrine hydrochloride 1.0%

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves nasal congestion due to:
      • common cold
      • hay fever
      • upper respiratory allergies
    • 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 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
    • 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.

  • Directions

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

    • store at 20-25°C (68-77°F)
    • retain carton for future reference on full labeling
  • Inactive ingredients

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

  • Questions or comments?

    call 1-855-565-5800 weekdays 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Foundation Consumer
    Healthcare, LLC.
    Pittsburgh, PA 15205

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Extra Strength

    Neo-
    Synephrine    ®
    Nasal Spray
    Phenylephrine HCl 1.0% Nasal Decongestant

    POWERFUL
    RELIEF
    you can
    use every
    4 HRS

    NON-DROWSY
    COLD +
    ALLERGY

    Nasal
    Congestion
    RELIEF

    Pharmacist
    Recommended

    1/2 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NEO-SYNEPHRINE   EXTRA STRENGTH
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-175
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69536-175-151 in 1 CARTON06/30/201707/01/2021
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:69536-175-211 in 1 CARTON06/30/201709/01/2018
    221 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 FINALpart34106/30/201707/01/2021
    Labeler - Foundation Consumer Healthcare LLC (079675882)
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