Label: NEO-SYNEPHRINE MAXIMUM- phenylephrine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Phenylephrine hydrochloride 1.0%

  • PURPOSE

    Nasal decongestant

  • INDICATIONS & USAGE

    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

    When using this product:

    • 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.
    • use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • DO NOT USE

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

    Do not use more than directed.

    Do not use for more than 3 days.

  • ASK DOCTOR

    Ask a doctor before use if you have:

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    Stop use and as a doctor if symptoms persist.

  • STOP USE

    Stop use and ask a doctor if symptoms persist.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • 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 then every 4 hours
    • Children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    • Store at room temperature, 59º - 86º F (15º -30º C)
    • Retain carton for future reference on full labeling
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Call 1-800-324-1880, 7:30 - 4:00 Central, Monday - Friday, or visit www.bfascher.com

  • PRINCIPAL DISPLAY PANEL

    Neo-Synephrine Extra Strength

  • INGREDIENTS AND APPEARANCE
    NEO-SYNEPHRINE MAXIMUM 
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0810
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0225-0810-4715 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2020
    Labeler - BF ASCHER AND CO INC (003854403)