Label: EQUALINE FAST ACTING- 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 November 3, 2014

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  • Active ingredient

    Phenylephrine hydrochloride 1%

  • Purpose

    Nasal decongestant

  • Uses

    for the temporary relief of nasal congestion due to:

    •
    common cold
    •
    hay fever
    •
    upper respiratory allergies
  • Warnings

  • 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 exceed recommended dosage

    • do not use for more than 3 days. Use only as directed

    • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

    • the use of this container by more than one person may spread infection

    • frequent or prolonged use may cause nasal congestion to recur or worsen

  • 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

    •
    adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more than every 4 hours
    •
    children under 12 years of age: ask a doctor
    •
    Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
  • Other information

    •
    store between 20°-25°C (68°-77°F)
    •
    container is filled to proper level for best spray action
  • Inactive Ingredients

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

  • Questions

    1-877-932-7948

    IMPORTANT: Keep this carton for future reference on full labeling

    DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

    Distributed By: Supervalu Inc.
    Eden Prairie, MN 55344

    This product is not manufactured or distributed by Novartis Consumer Health Inc., the owner of the registered trademark 4-Way Fast Acting Nasal Spray.

  • Principal Display

    NDC 41163-728-01

    Equaline

    Fast Acting

    Nasal Spray

    Phenylephrine hydrochloride 1%

    (nasal decongestant)

    fast acting relief of

    •
    nasal congestion
    •
    sinus congestion
    •
    sinus pressure
    •
    swollen nasal passages

    1 FL OZ (30mL)

    Equaline Nasal Spray
  • INGREDIENTS AND APPEARANCE
    EQUALINE  FAST ACTING
    phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-728
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-728-011 in 1 CARTON
    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 finalpart34110/30/2014
    Labeler - SUPERVALU INC. (006961411)
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