Label: NAPHAZOLINE HCI AND PHENIRAMINE MALEATE- naphazoline hydrochloride , pheniramine maleate solution/ drops

  • NDC Code(s): 59390-177-13
  • Packager: Altaire Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 28, 2020

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  • 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)

  • PRINCIPAL DISPLAY PANEL

    IL15

  • PRINCIPAL DISPLAY PANEL

    OL15

  • INGREDIENTS AND APPEARANCE
    NAPHAZOLINE HCI AND PHENIRAMINE MALEATE 
    naphazoline hydrochloride , pheniramine maleate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-177
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.27 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59390-177-1315 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/06/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07820810/06/2010
    Labeler - Altaire Pharmaceuticals Inc. (786790378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altaire Pharmaceuticals Inc.786790378manufacture(59390-177)
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