Label: LEADER AZO TABS URINARY TRACT ANALGESIC- phenazopyridine hydrochloride tablet

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

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Drug Label Information

Updated January 3, 2011

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  • ACTIVE INGREDIENT

    Phenazopyridine Hydrochloride 95 mg

  • PURPOSE

    Purpose;


    Urinary Analgesic

  • INDICATIONS & USAGE

    Uses

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

    urinary tract infections.

  • WARNINGS

    Do not exceed recommended dosage

  • ASK DOCTOR

    Ask a Doctor before use if you have

    kidney disease,
    allergies to foods,preservatives or dyes,

    had a hypersensitive reaction to phenazopyridine.

  • WHEN USING

    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

    Stop use and ask a doctor if

    if your symptoms last for more than 2 days

    you suspect you are having an adverse reaction

    to the medication.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    in case of an overdose,get medical help or contact

    a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    magnesium stearate,microcrystalline cellulose.May also contain carnauba wax,

    croscarmellose sodium,hypromellose,lactose,magnesium silicate,maize starch,pharmaceutical

    glaze,polyethylene glycol,povidone,pregelatinized starch,sodium starch glycolate.

  • PRINCIPAL DISPLAY PANEL

    image of carton
  • INGREDIENTS AND APPEARANCE
    LEADER AZO TABS URINARY TRACT ANALGESIC 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-308
    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)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code CPC64;A5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-308-011 in 1 CARTON
    1NDC:37205-308-6432 in 1 CELLO PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/05/2004
    Labeler - Cardinal Health (097537435)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel, repack
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