Label: TOPCARE MAXIMUM STRENGTH 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 January 30, 2019

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  • ACTIVE INGREDIENT

     PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

  • PURPOSE

    URINARY ANALGESIC

  • WARNINGS

    DO NOT EXCEED RECOMMENDED DOSAGE

  • ASK DOCTOR SECTION

    ASK DOCTOR BEFORE USE

    IF YOU HAVE KIDNEY DISEASE

    ALLERGIES TO FOODS,PRESERVATIVES OR DYES

    HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

  • WHEN USING SECTION

    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 SECTION

    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

  • PREGNANCY OR BREAST FEEDING

    ASK A HEALTH PROFESSIONAL BEFORE USE

  • KEEP OUT OF REACH OF CHILDREN

    IN CASE OF OVERDOSE ,GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • INDICATIONS & USAGE

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

  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

    pharmaceutical glaze, and sodium starch glycolate.

  • PRINCIPAL DISPLAY PANEL

    image of carton
  • INGREDIENTS AND APPEARANCE
    TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE97.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 975
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-103-011 in 1 CARTON02/01/2011
    1NDC:36800-103-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2011
    Labeler - TOPCO ASSOCIATES LLC (006935977)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(36800-103) , repack(36800-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.057795122manufacture(36800-103)
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