VISINE ALLERGY EYE RELIEF MULTI-ACTION (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]

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  • VISINE ALLERGY EYE RELIEF MULTI-ACTION (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]

VISINE ALLERGY EYE RELIEF MULTI-ACTION (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]
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NDC 69968-0367-1, 69968-0367-2
Set ID 125fbc97-5bc8-436e-9ee9-e5a44384e260
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc.
Generic Name
Product Class
Product Number
Application Number NDA020485
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Naphazoline HCl 0.025%Redness reliever
    Pheniramine maleate 0.3%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 becomes 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 4 times a day
    • children under 6 years of age: consult a doctor
  • Other information

    • Store at 15° to 25°C (59° to 77°F)
  • Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium hydroxide and/or hydrochloric acid

  • Questions?

    call toll-free 888-734-7648 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    VISINE®

    NAPHAZOLINE HCl 0.025%
    AND PHENIRAMINE MALEATE 0.3%
    OPHTHALMIC SOLUTION
    ANTIHISTAMINE AND REDNESS RELIEVER

    ALLERGY EYE RELIEF
    MULTI-ACTION

    ORIGINAL
    PRESCRIPTION STRENGTH

    Clinically Proven to
    Relieve Red,
    Itchy Eyes

    STERILE
    EYE DROPS

    1/2 FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE ALLERGY EYE RELIEF MULTI-ACTION 
    naphazoline hydrochloride and pheniramine maleate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0367
    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
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0367-11 in 1 CARTON05/06/2019
    115 mL in 1 BOTTLE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    2NDC:69968-0367-22 in 1 CARTON06/03/2019
    215 mL in 1 BOTTLE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02048505/06/2019
    Labeler - Johnson & Johnson Consumer Inc. (002347102)
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