QUALITY CHOICE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

QUALITY CHOICE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-077-01
Set ID fa50c330-6fbe-4a7f-8625-3228db558933
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves nasal congestion due to:
    common cold
    hay fever
    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
    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 at (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 Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

  • Other information

    store at room temperature
    retain carton for future reference on full labeling

    SAFETY SEALED: Do not use if printed seal over cap is broken or missing

    How to use:

    Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

  • Package/Label Principal Display Panel

    QUALITY CHOICE®

    NDC# 63868-077-01

    *Compare to Active Ingredient Afrin® No Drip Original

    12 hour relief

    Nasal Mist No Drip

    Nasal Decongestant

    Oxymetazoline HCl 0.05%

    Nasal Solution

    Fast and Powerful Congestion Relief

    For Colds & Allergies

    No Drip Pump Mist Won’t Drip from Nose or Down Throat

    Maximum Strength

    Original

    1 FL OZ (30mL)

    IMPORTANT: Keep the carton for future labeling.

    100% QC SATISFACTION GURANTEED

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 800-935-2362

    *This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Original.

    Quality Choice Nasal mist Oxymetazoline HCl
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE NASAL  ORIGINAL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-077
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-077-011 in 1 CARTON04/17/2019
    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 finalpart34104/17/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)

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