Label: DOLLAR GENERAL- nasal phenylephrine hydrochloride spray

  • NDC Code(s): 55910-827-30
  • Packager: DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)
  • 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 15, 2023

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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 at 1-800-222-1222.

  • Directions

    ▪
    adults and children 12 years of age & older: 2 or 3 sprays in each nostril not more often 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 at room temperature
    ▪
    container is filled to proper level for best spray action
  • Inactive ingredients

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

  • Principal Display Panel

    NDC 55910-827-30

    Since 1903

    Rexall®

    Nasal Spray

    Nasal Decongestant

    Phenylephrine Hydrochloride 1 %

    Fast Acting Relief of:

    •
    Nasal congestion
    •
    Sinus congestion
    •
    Sinus pressure
    •
    Swollen nasal membranes

    1 FL OZ (30mL)

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

    Visit us at: Rexall.com

    PACKAGED FOR DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072 USA

    IMPORTANT: Keep this carton for future reference on full labeling.
    Nasal Spray Phenylephrine HCl 1%
  • INGREDIENTS AND APPEARANCE
    DOLLAR GENERAL 
    nasal phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-827
    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)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-827-301 in 1 CARTON05/20/2019
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/20/2019
    Labeler - DOLGENCORP, INC. (DOLLAR GENERAL & REXALL) (068331990)
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