Label: AVON HEXASHIELD CONGESTION RELIEF ORIGINAL- oxymetazoline hydrochloride spray

  • NDC Code(s): 43136-105-01
  • Packager: Tai Guk Pharm. Co., Ltd.
  • 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 July 31, 2019

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  • Active Ingredient

    Oxymetazoline HCl 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

    For external use only.

    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.

  • 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: Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • retain carton for future reference on full labeling
  • Inactive Ingredients

    benzalkonium chloride, edetate disodium, polyethylene glycol 400, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasi dihydrate, water

  • Questions or comments?

    Call toll free 1-800-FOR-AVON

    www.avon.com

  • Principal Display Panel

    HeXasheild

    ORIGINAL

    NASAL RELIEF SPRAY

    CONGESTION RELIEF

    Oxymetazoline HCl-

    Nasal Decongestant

    Compare to the active ingredient in Afrin ® Original

    Rapid & Powerful Congestion

    Relief 12 Hour Relief

    AVON

    • Original Nasal Spray - 12 HOURS
    • Pump Mist
    • Anti-Drip

    NET WT 0.5 FL oz (15 mL)

    AVON NASAL RELIEF SPRAY

  • INGREDIENTS AND APPEARANCE
    AVON HEXASHIELD CONGESTION RELIEF  ORIGINAL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-105
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43136-105-011 in 1 CARTON07/31/2019
    115 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 finalpart34107/31/2019
    Labeler - Tai Guk Pharm. Co., Ltd. (689060246)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(43136-105)
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