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 August 21, 2018

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  • 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 DOCTOR

    • narrow angle glaucoma
    • heart disease
    • high blood pressure
    • trouble urinating
  • WHEN USING

    • 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

    • 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 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.

  • DOSAGE & ADMINISTRATION

    • 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
  • INACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

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

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

    • Redness Reliever and Antihistamine Eye Drops
    • Relieves Itching & Redness
    • EYE ALLERGY RELIEF
  • ACTIVE INGREDIENT

    Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NAPHCON A 
    naphazoline hydrochloride and pheniramine maleate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-107
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-107-0315 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02022601/26/2016
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894relabel(52959-107) , repack(52959-107) , manufacture(52959-107)
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