NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE SOLUTION/ DROPS [AKORN, INC.]

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NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE SOLUTION/ DROPS [AKORN, INC.]
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NDC 17478-065-12
Set ID 78c5250c-b27c-4b1d-a4b8-571973ac3ae4
Category HUMAN OTC DRUG LABEL
Packager Akorn, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA202795
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  • 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

    When using this product

    • pupils may become enlarged temporarily causing light sensitivity
    • 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
    • some users may experience a brief tingling sensation

    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

    • 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 (0.1%), Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for Injection.

  • Questions?

    Call toll-free

    1-800-932-5676

  • 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
  • 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

    ► Relieves 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
  • INGREDIENTS AND APPEARANCE
    NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 
    naphazoline hydrochloride and pheniramine maleate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-065
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.25 mg  in 1 mL
    Pheniramine Maleate (UNII: NYW905655B) (Pheniramine - UNII:134FM9ZZ6M) Pheniramine Maleate3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-065-121 in 1 CARTON01/24/2013
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20279501/24/2013
    Labeler - Akorn, Inc. (117696770)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc117696790PACK(17478-065) , LABEL(17478-065)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc. 117696832MANUFACTURE(17478-065) , ANALYSIS(17478-065) , STERILIZE(17478-065)
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