Label: PREFERRED URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

  • NDC Code(s): 10956-551-30
  • Packager: Reese Pharmaceutical Co
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 6, 2019

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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
    PREFERRED URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-551
    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:10956-551-301 in 1 CARTON07/27/2016
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2013
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(10956-551) , repack(10956-551)