Label: NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE- naphazoline hydrochloride and pheniramine maleate solution/ drops 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Naphazoline Hydrochloride 0.025%

    Pheniramine Maleate 0.3%

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  • Purpose

    Redness reliever

    Antihistamine

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  • Uses

    Temporarily relieves itchy, red eyes due to:

    • pollen
    • ragweed
    • grass
    • animal hair and dander
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  • 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 become 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.

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  • 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
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  • Other information

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

    Boric Acid and Sodium Borate buffer system preserved with Benzalkonium Chloride (0.01%) and Edetate Disodium (0.1%),Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for Injection.

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  • Questions?

    Call toll-free 1-800-932-5676

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-065-12

    Naphazoline HCl 0.025%

    and

    Pheniramine Maleate 0.3%

    Ophthalmic Solution, USP

    ANTIHISTAMINE & REDNESS

    RELIEVER

    Eye Allergy

    Relief Eye Drops

    Sterile

    15 mL (0.5 fl. oz.)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-065-12

    Naphazoline HCl 0.025%

    and

    Pheniramine Maleate 0.3%

    Ophthalmic Solution, USP

    ANTIHISTAMINE & REDNESS

    RELIEVER

    Eye Allergy

    Relief Eye Drops

    ► Relives Redness

    ► Relieves itchy Eyes Due To:

    Pollen ● Ragweed ● Grass

    Animal Hair & Dander

    Sterile

    15 mL (0.5 fl. oz.)

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 
    naphazoline hydrochloride and pheniramine maleate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17478-065
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride 0.25 mg  in 1 mL
    Pheniramine Maleate (Pheniramine) Pheniramine Maleate 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Boric Acid  
    Sodium Borate  
    Benzalkonium Chloride  
    Edetate Disodium  
    Sodium Hydroxide  
    Hydrochloric Acid  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-065-12 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202795 01/24/2013
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 063434679 PACK(17478-065), LABEL(17478-065)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 155135783 MANUFACTURE(17478-065), ANALYSIS(17478-065), STERILIZE(17478-065)
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