QUALITY CHOICE (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION]

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QUALITY CHOICE (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-697-30
Set ID a12e2e66-d2f3-47a6-a915-a309ae828d27
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient

    Phenylephrine hydrochloride 1%

  • Purpose

    Nasal decongestant

  • Uses

    for the temporarily relief 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 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 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 (1-800-222-1222).

  • Directions

    •
    adults and children 12 years of age and older: 2 or 3 drops 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

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC# 63868-697-30

    *Compare to Active Ingredient in 4-Way® Fast Acting Nasal Spray

    Nasal Spray

    Nasal Decongestant

    PHENYLEPHRINE HCl 1%

    For Relief of:

    Nasal Congestion

    Sinus Congestion

    Sinus Pressure

    Swollen Nasal Membranes

    100% QC SATISFACTION GUARANTEED

    1 FL OZ (30 mL)

    Distributed by: C.D.M.A. Inc. ©

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

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

    Quality Choice Nasal Spray Phenylephrine HCl
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-697
    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 (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-697-301 in 1 CARTON12/18/2018
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/18/2018
    Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)
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