Label: LEADER URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 2, 2014

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  • Active Ingredient

    Phenazopyridine Hydrochloride 95 mg

  • Purpose

    Urinary Analgesic

  • Uses

    fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

  • Warning

    Do not exceed recommended dosage

  • Ask Doctor before use if you have


    ■ kidney disease
    ■ allergies to foods, preservatives or dyes
    ■ had a hypersensitive reaction to Phenazopyridine

  • When using this product

    ■ When using this product   stomach upset may occur, taking this product with or after meals may reduce stomach upset
    ■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.

  • Stop use and ask a doctor if

    ■ your symptoms last for more than 2 days
    ■ you suspect you are having an adverse reaction to the medication  

  • If pregnant or breast feeding

    ask a health professional before use.

  • Keep out of the reach of children

    in case of an overdose,get medical help or contact a Poison Control Center right away.

  • Directions


    ■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
    ■ Children under 12: consult a doctor
    ■ Do not use for more than 2 days (12 tablets) without consulting a doctor

  • Inactive Ingredients

    lactose, magnesium silicate, magnesium stearate, microcrystalline

    cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,

    croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.

  • PRINCIPAL DISPLAY PANEL

    image of carton
  • INGREDIENTS AND APPEARANCE
    LEADER URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE95 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code P95
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-031-301 in 1 CARTON
    130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2013
    Labeler - Cardinal Health (097537435)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(49781-031) , repack(49781-031)
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