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

  • NDC Code(s): 24208-430-03, 24208-430-15, 24208-430-30, 24208-430-45
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 11, 2020

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?

    [phone icon] Call: 1-800-553-5340

    Distributed by:
    Bausch + Lomb, a division
    of Bausch Health US LLC
    Bridgewater, NJ 08807 USA

    3844800
    AB5529

  • Package/Label Principal Display Panel

    cartontwinpack.jpg

    TWIN PACK

    BAUSCH + LOMB

    Opcon-A®
    pheniramine maleate 0.315% and naphazoline
    hydrochloride 0.02675% ophthalmic solution
    ANTIHISTAMINE AND REDNESS RELIEVER EYE DROPS

    CLINICALLY PROVEN
    EYE ALLERGY RELIEF

    itching + redness

    caused by pollen, ragweed, grass, animal hair and dander

    [teardrop icon]

    2 x 15 mL BOTTLES
    STERILE (0.5 FL OZ EACH)

  • INGREDIENTS AND APPEARANCE
    OPCON-A 
    naphazoline hydrochloride and pheniramine maleate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-430
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-430-031 in 1 CARTON08/06/1994
    13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:24208-430-151 in 1 CARTON08/06/1994
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:24208-430-301 in 1 CARTON08/06/1994
    330 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:24208-430-452 in 1 CARTON07/01/2015
    415 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02006506/08/1994
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(24208-430)