EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]

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EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DOLGENCORP, LLC]
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NDC 55910-552-15
Set ID 82a99ff3-4f57-42e6-82f4-769d6418be7c
Category HUMAN OTC DRUG LABEL
Packager DOLGENCORP, LLC
Generic Name
Product Class
Product Number
Application Number NDA020065
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  • Active ingredients

    Naphazoline HCl (0.02675%)

    Pheniramine maleate (0.315%)

  • Purpose

    Redness reliever

    Antihistamine

  • Uses

    •
    temporarily relieves itching and redness caused by 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
    •
    if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    •
    heart disease
    •
    high blood pressure
    •
    trouble urinating due to an enlarged prostate gland
    •
    narrow angle glaucoma

    When using this product

    •
    overuse may cause more eye redness
    •
    pupils may become enlarged temporarily
    •
    do not touch tip of container to any surface to avoid contamination
    •
    you may feel a brief tingling after putting drops in eye
    •
    replace cap after use
    •
    remove contact lenses before using

    Stop use and ask a doctor if you experience

    •
    eye pain
    •
    changes in vision
    •
    redness or irritation of the eye that 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 oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

  • Directions

    •
    Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
    •
    Children under 6 years: ask a doctor
  • Other information

    •
    store at 20°-25° C (68°-77° F)
    •
    protect from light
    •
    use before expiration date marked on the carton or bottle
  • Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride. Hydrochloric acid may be used to adjust pH.

  • Questions?

    Call: 1-888-309-9030

  • Package/Label Principal Display Panel

    carton.jpg

    DG health

    Allergy
    Relief
    Eye Drops

    Pheniramine
    Maleate
    0.315% and
    Naphazoline
    Hydrochloride
    0.02675%
    Ophthalmic Solution

    •
    Itching and redness
    reliever eye drops
    •
    Sterile

    0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    EYE ALLERGY RELIEF 
    pheniramine maleate and naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-552
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.2675 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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-552-151 in 1 CARTON07/01/2015
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02006507/01/2015
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(55910-552)
    Establishment
    NameAddressID/FEIBusiness Operations
    Loba Feinchemie AG300137478API MANUFACTURE(55910-552)
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