Label: TODAYS HEALTH SINUS NASAL RELIEF- oxymetazoline hydrochloride spray

  • 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 October 25, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                   Purpose

    Oxymetazoline hydrochloride 0.05% ......................................Nasal decongestant

  • PURPOSE

    Uses

    • temporarily relieves nasal congestion due to
    • common cold
    • hay fever
    • upper respiratory allergies
    • sinusitis
    • shrinks swollen nasal membranes so you can breathe more freely
  • WARNINGS

    For external use only

  • ASK DOCTOR

    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

    When using this product

    • do not use more than directed
    • do not use 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

    Stop use and ask a doctor if symptoms persist

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Don not exceed 2 doses in any 24-hour period.
    • children under 6 years of age : ask a doctor.  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.
  • STORAGE AND HANDLING

    Other information

    • store between 15o to 25oC (59o and 77oF)
    • retain carton for future reference on full labeling
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride solution, edetate disodium, polyethylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Today's Health, Inc.

    4300 Sisk Road, #C

    Modesto, CA 95356



    Questions or comments

    Call toll free 1-800-605-0236

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    TODAYS HEALTH SINUS NASAL RELIEF 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0012
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-0012-81 in 1 CARTON
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/25/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAI GUK PHARM. CO., LTD.631101656manufacture
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