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Naphazoline HCI And Pheniramine Maleate (Altaire Pharmaceuticals Inc.)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 15 mL in 1 BOTTLE, DROPPER (59390-177-13) Label Information

Complete Naphazoline HCI And Pheniramine Maleate Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Naphazoline Hydrochloride (0.027%)

    Pheniramine Maleate (0.315%)


  • PURPOSE

    Purpose

    Redness Reliever

    Antihistamine


  • INDICATIONS & USAGE

    Uses: temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.


  • WARNINGS

    Warnings: if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a physician. Do not use in children under 6 years of age unless directed by a physician. If this solution changes color or becomes cloudy, do not use. Overuse of this product may produce increased redness of the eye.

    If you are sensitive to any ingredient in this product, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.


  • DO NOT USE

    Do not use if imprinted seal on cap is torn, broken or missing, or if imprinted seals on top ad bottom flaps are not intact and completely legible.


  • ASK DOCTOR

    Ask a doctor before use if  you have

    • heart disease
    • high blood pressure
    • trouble urinating due to enlarged prostrate gland
    • narrow angle glaucoma

  • WHEN USING

    Remove contact lenses before using.


  • STOP USE

    Stop use and ask a doctor if you experience: eye pain, changes in vision, redness or irritation of the eye that worsens or persists for more than 72 hours. Overuse of this product may produce increased redness of the eye. Pupils may become enlarged temporarily. You may experience a brief tingling sensation after putting drops in eyes.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.


  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 6 years of age and older: instill 1 or 2 drops in affected eye(s) up to 4 times daily.

    Children under 6 years: ask a doctor.


  • STORAGE AND HANDLING

    Store at room temperature 20 degrees - 25 degrees C ( 68 degrees - 77 degrees F).

    Protect from light.


  • SPL UNCLASSIFIED SECTION

    Use before expiration date marked on the carton or bottle.

    Available in 15mL NDC 59390-177-13 and 30 mL NDC 59390-177-18


  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride 0.01%, boric acid, edetate disodium 0.1%, hypromellose, purified water, sodium borate, and sodium chloride.


  • QUESTIONS

    Questions or comments

    Call (631) 722-5988 9am - 5pm EST Monday - Friday


  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Altaire Pharmaceuticals, Inc.

    Aquebogue, N.Y. 11931


  • PRINCIPAL DISPLAY PANEL

    ALTAIRE Pharmaceuticals, Inc.

    Aquebogue, N.Y. 11931


    Naphazoline HCI 0.027%

    and

    Pheniramine Maleate 0.315%


    Ophthalmic Solution, USP

    Eye Allergy Relief

    With Antihistamine To Relieve Itching


    Itching and Redness Reliever
    Eye Drops

    0.5 Fl. OZ. (15mL)

  • INGREDIENTS AND APPEARANCE
    NAPHAZOLINE HCI AND PHENIRAMINE MALEATE 
    naphazoline hydrochloride , pheniramine maleate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59390-177
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.027 mL  in 100 mL
    PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE 0.315 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59390-177-13 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078208 10/06/2010
    Labeler - Altaire Pharmaceuticals Inc. (786790378)
    Establishment
    Name Address ID/FEI Business Operations
    Altaire Pharmaceuticals Inc. 786790378 manufacture