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

Drug Label Information

Updated 04/13

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 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.

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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 or Comments?

    1-800-932-5676

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    Well at

    Walgreens

    NDC 0363-9650-02

    STERILE

    Allergy

    Eye Drops

    Naphazoline HCl 0.025% and

    Pheniramine Maleate 0.3%

    Ophthalmic Solution, USP

    Antihistamine & Redness Reliever

    Relieves redness & itchy eyes

    0.5 FL OZ (15 mL)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Well at

    Walgreens

    NDC 0363-9650-02

    WALGREENS PHARMACIST RECOMMENDED‡

    STERILE

    Allergy

    Eye Drops

    Naphazoline HCl 0.025% and

    Pheniramine Maleate 0.3%

    Ophthalmic Solution, USP

    Antihistamine & Redness Reliever

    Relieves redness &

    itchy eyes due to:

    • Pollen
    • Ragweed ● Grass
    • Animal hair & dander

    Compare to Visine-A® active ingredients#

    0.5 FL OZ (15 mL)

    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 Item Code (Source) NDC:0363-9650
    Route of Administration OPHTHALMIC DEA Schedule     
    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:0363-9650-02 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 04/23/2013
    Labeler - Walgreens (008965063)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 063434679 PACK(0363-9650) , LABEL(0363-9650)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 155135783 MANUFACTURE(0363-9650) , ANALYSIS(0363-9650) , STERILIZE(0363-9650)
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