Home > Drugs A-Z > Naphazoline Hydrochloride and Pheniramine Maleate

Naphazoline Hydrochloride and Pheniramine Maleate (CVS Pharmacy)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (59779-365-01) > 15 mL in 1 BOTTLE, DROPPER Label Information

Complete Naphazoline Hydrochloride and Pheniramine Maleate Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredients

    Naphazoline Hydrochloride 0.025%

    Pheniramine Maleate 0.3%


  • Purpose

    Redness reliever

    Antihistamine


  • Uses

    Temporarily relieves itchy, red eyes due to:

    • 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

    Ask a doctor before use if you have
    • heart disease
    • high blood pressure
    • narrow angle glaucoma
    • trouble urinating due to an enlarged prostate gland

    When using this product
    • pupils may become enlarged temporarily
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • overuse may cause more eye redness

    Stop use and ask a doctor if
    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition 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 swallowing by infants and children may lead to coma and marked reduction in body temperature.


  • Directions

    • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day
    • children under 6 years of age: consult a doctor

  • Other information

    • some users may experience a brief tingling sensation
    • store between 20° to 25°C (68° to 77°F).

  • Inactive ingredients

    Boric Acid and Sodium Borate buffer system preserved with Benzalkonium Chloride (0.01%) and Edetate Disodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for injection.


  • Questions or comments?

    1-800-579-8327


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    CVS Healthâ„¢ Logo

    NDC 59779-365-01

    Naphazoline HCl 0.025%

    Pheniramine Maleate 0.3%

    Ophthalmic Solution, USP

    Allergy

    Eye Drops

    ANTIHISTAMINE &

    REDNESS RELIEVER

    RELIEVES REDNESS

    & ITCHY EYES

    STERILE

    15 mL (0.5 FL OZ)

    Principal Display Panel Text for Container Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    CVS Healthâ„¢ Logo Compare to the active

    ingredient in Visine-A®*

    NDC 59779-365-01

    Allergy

    Eye Drops

    Naphazoline HCl 0.025%

    Pheniramine Maleate 0.3%

    Ophthalmic Solution, USP

    ANTIHISTAMINE &

    REDNESS RELIEVER

    RELIEVES REDNESS &

    ITCHY EYES DUE TO:

    Pollen

    Ragweed

    Grass

    Animal hair

    & dander

    STERILE

    15 mL (0.5 FL OZ)

    Principal Display Panel Text for Carton Label

  • INGREDIENTS AND APPEARANCE
    NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 
    naphazoline hydrochloride and pheniramine maleate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-365
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride 0.25 mg  in 1 mL
    Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M) Pheniramine Maleate 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Boric Acid (UNII: R57ZHV85D4)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-365-01 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202795 01/25/2013
    Labeler - CVS Pharmacy (062312574)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 063434679 PACK(59779-365) , LABEL(59779-365)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 155135783 MANUFACTURE(59779-365) , ANALYSIS(59779-365) , STERILIZE(59779-365)