Label: EYE ALLERGY RELIEF- pheniramine maleate and naphazoline hydrochloride solution/ drops

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

Drug Label Information

Updated November 22, 2021

If you are a consumer or patient please visit this version.

  • Active ingredients

    Naphazoline HCl (0.02675%)

    Pheniramine maleate (0.315%)

  • Purpose

    Redness reliever

    Antihistamine

  • Uses

    temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.
  • Warnings

    For external use only

    Do not use

    if you are sensitive to any ingredient in this product
    if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    trouble urinating due to an enlarged prostate gland
    narrow angle glaucoma

    When using this product

    overuse may cause more eye redness
    pupils may become enlarged temporarily
    do not touch tip of container to any surface to avoid contamination
    you may feel a brief tingling after putting drops in eye
    replace cap after use
    remove contact lenses before using

    Stop use and ask a doctor if you experience

    eye pain
    changes in vision
    redness or irritation of the eye that worsens 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 oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

  • Directions

    Adults and children 6 years of age and older: Instill 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)
    this package is child-resistant
    protect from light
    use before expiration date marked on the carton or bottle
  • Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride. Hydrochloric acid may be used to adjust pH.

  • Questions or Comments?

    Call: 1-800-910-6874

  • Package/Label Principal Display Panel

    carton

    NDC 11673-430-15

    Compare to active ingredient
    in Opcon-A*

    eye allergy
    relief drops

    Pheniramine Maleate 0.315%
    and Naphazoline Hydrochloride
    0.02675% Ophthalmic Solution

    ITCHING AND REDNESS
    RELIEVER EYE DROPS

    relieves itching and redness caused
    by grass, ragweed, pollen, animal hair
    and dander

    [drop icon]
    [arrow icon] up & up™

    STERILE 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    EYE ALLERGY RELIEF 
    pheniramine maleate and naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-430
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.2675 mg  in 1 mL
    PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE3.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-430-151 in 1 CARTON08/31/2010
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02006508/31/2010
    Labeler - Target Corporation (006961700)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(11673-430)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(11673-430)