MULTI-ACTION RELIEF (POLYVINYL ALCOHOL, POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]

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MULTI-ACTION RELIEF (POLYVINYL ALCOHOL, POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]
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NDC 59390-156-13
Set ID 28f54146-fa76-4436-95d8-9dd9079f6c22
Category HUMAN OTC DRUG LABEL
Packager Altaire Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • SPL UNCLASSIFIED SECTION

    Multi-Action Relief Drops
    15mL
    NDC 59390-156-13

      

                  

    Drug Facts

  • Active ingredients

    Polyvinyl alcohol 0.5%

    Povidone 0.6%

    Tetrahydrozoline hydrochloride 0.05%

  • Purpose

    Lubricant

    Lubricant

    Redness Reliever

  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a protectant against further irritation or to relieve dryness of the eye
    • relieves redness of the eye due to minor eye irritations
  • Warnings

    For use in the eye(s) only.

    Do not use if

    solution changes color or becomes cloudy.

    Ask a doctor before use if you have

    narrow angle glaucoma.

    When using this product 

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using 
    • overuse may produce increased redness of the eye
    • pupils may become enlarged temporarily

    Stop use and ask a doctor if 

    • you experience eye pain
    • you experience changes in vision 
    • you experience continued redness or irritation of the eye 
    • the condition worsens 
    • symptoms last for more than 72 hours

    Keep out of reach of children. 

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions 

    • Instill 1 or 2 drops in the affected eye(s) up to four times daily.
  • Other Information 

    • store at room temperature.
    • remove contact lenses before using
    • tamper evident: Do not use if imprinted neckband on bottle is torn, broken or missing.
  • Inactive ingredients 

    benzalkonium chloride, dextrose, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    Multi-Action
    RELIEF DROPS
    LUBRICANT/REDNESS
    RELIEVER EYE DROPS
    STERILE
    0.5 FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL Multi-Action RELIEF DROPS LUBRICANT/REDNESS RELIEVER EYE DROPS STERILE 0.5 FL OZ (15mL)

  • INGREDIENTS AND APPEARANCE
    MULTI-ACTION RELIEF 
    polyvinyl alcohol, povidone and tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-156
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59390-156-131 in 1 CARTON05/09/2009
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34905/09/2009
    Labeler - Altaire Pharmaceuticals Inc. (786790378)
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