Label: EQUATE EYE ALLERGY RELIEF DROPS- naphazoline hydrochloride, pheniramine maleate solution/ drops

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

Drug Label Information

Updated April 20, 2018

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  • SPL UNCLASSIFIED SECTION

    Walmart

    Equate

    Eye Allergy Relief Drops 15mL

    NDC 49035-874-13

    Drug Facts

  • Active ingredients

    Naphazoline HCl (0.027%)

    Pheniramine Maleate(0.315%)

  • Purpose

    Redness Reliever

    Antihistamine

  • Uses

    • temporarily relieves itching and redness caused by pollen, ragweed, animal hair and dander.
  • Warnings

    Do not use

    • if you are sensitive to any ingredient in this product.
    • if this product changes color or becomes cloudy.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • trouble urinating due to 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(s) 
    • replace cap after using
    • 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 persists for 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 of 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 room temperature 20°-25°C (68°-77°F).
    • protect from light
    • use before expiration date marked on carton or bottle
  • Inactive ingredients

    benzalkonium chloride 0.01%, boric acid, edetate disodium 0.1%, hypromellose, purified water, sodium borate and sodium chloride.

  • Questions?

    Call: 1 888- 287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-874-13
    equate
    Eye Allergy
    Relief Drops
    Itching and Redness
    Reliever Eye Drops

    NDC 49035-874-13 equate Eye Allergy Relief Drops Itching and Redness Reliever Eye Drops

  • INGREDIENTS AND APPEARANCE
    EQUATE EYE ALLERGY RELIEF DROPS 
    naphazoline hydrochloride, pheniramine maleate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-874
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.27 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-874-1315 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07820803/08/2018
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Altaire Pharmaceuticals, Inc. (786790378)
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