Label: NAPHCON A- naphazoline hydrochloride and pheniramine maleate solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 25, 2023

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  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Naphazoline hydrochloride 0.025%Redness reliever
    Pheniramine maleate 0.3%Antihistamine
  • Uses

    for the temporary relief of redness and itching of the eye(s) due to:

    • ragweed
    • pollen
    • grass
    • animal dander and hair
  • Warnings

    For external use only

  • Do not use

    • if you are sensitive to any ingredient in this product
    • if this solution changes color or becomes cloudy
  • Ask a doctor before use if you have

    • narrow angle glaucoma
    • heart disease
    • high blood pressure
    • trouble urinating
  • When using this product

    • pupils may become enlarged temporarily causing light sensitivity
    • overuse may cause more eye redness
    • remove contact lenses before using
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after each use
  • Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
  • Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

  • Directions

    • adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years: ask a doctor
  • Other information

    • store at 20°-25°C (68°-77°F)
    • protect from light
  • Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

  • Questions?

    In the U.S. call 1-800-757-9195 or visit www.alcon.com

  • HOW SUPPLIED

    Product: 50090-0185

    NDC: 50090-0185-0 15 mL in a BOTTLE / 1 in a CARTON

  • naphazoline hydrochloride and pheniramine maleate

    Label Image
  • INGREDIENTS AND APPEARANCE
    NAPHCON A  
    naphazoline hydrochloride and pheniramine maleate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0185(NDC:0065-0085)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.25 mg  in 1 mL
    PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0185-01 in 1 CARTON11/28/2014
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02022606/08/1994
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0185)
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