QUALITY CHOICE MAXIMUM STRENGTH (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CHAIN DRUG MARKETING ASSOCIATION]

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QUALITY CHOICE MAXIMUM STRENGTH (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-698-30
Set ID a87ba15f-b5a9-4983-a721-ca7f705aea86
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    •
    temporarily relief of nasal congestion due to the ,common cold, hay fever or other upper respiratory allergies
    •
    temporarily relieves sinus congestion and pressure
    •
    shrinks swollen nasal membranes so you can breathe more freely
  • Warnings

  • Ask a doctor before use if you have

    •
    heart disease
    •
    high blood pressure
    •
    diabetes
    •
    thyroid disease
    •
    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 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    •
    children under 6 years of age: ask a doctor

    To Spray: squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

  • Other information

    •
    store at room temperature
  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    QUALITY CHOICE

    NDC# 63868-698-30

    *Compare to the Active Ingredient in AFRIN® Original Nasal Spray

    Nasal Spray

    Oxymetazoline HCl 0.05%

    Nasal Decongestant

    Original

    Fast, Powerful Congestion Relief

    For Colds & Allergies

    12 Hour

    Maximum Strength

    1 FL OZ (30 mL)

    100% QC SATISFACTION GURANTEED

    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 Bayer Healthcare LLC, distributer of Afrin® Original.

    QC Nasal Spray Oxymetazoline HCl
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE  MAXIMUM STRENGTH
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-698
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-698-301 in 1 CARTON12/17/2018
    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 finalpart34112/17/2018
    Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)
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