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

  • NDC Code(s): 11822-0552-1, 11822-0552-2
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 22, 2024

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  • 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: 1-866-767-8975

  • Package/Label Principal Display Panel

    carton

    TWIN PACK

    Compare to Opcon-A®
    active ingredients*

    NDC 11822-0552-2

    EYE ALLERGY

    RELIEF DROPS

    pheniramine maleate 0.315% and

    naphazoline hydrochloride 0.02675%

    ophthalmic solution

    ANTIHISTAMINE AND

    REDNESS RELIEVER

    STERILE

    2 ×15 mL BOTTLES

    (0.5 FL OZ EACH)

  • INGREDIENTS AND APPEARANCE
    EYE ALLERGY RELIEF 
    pheniramine maleate and naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0552
    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:11822-0552-11 in 1 CARTON07/01/2015
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:11822-0552-22 in 1 CARTON07/01/2015
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02006507/01/2015
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625manufacture(11822-0552)
    Establishment
    NameAddressID/FEIBusiness Operations
    Loba Feinchemie AG300137478api manufacture(11822-0552)
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