Label: WALGREENS URINARY PAIN RELIEF MAXIMUM STRENGTH- phenazopyridine hydrochloride tablet

  • NDC Code(s): 0363-0113-01, 0363-0113-12
  • Packager: Walgreens 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 January 16, 2019

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  • ACTIVE INGREDIENT

    PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

  • PURPOSE

    PHENAZOPYRIDINE HYDROCHLORIDE                     URINARY ANALGESIC

  • WARNINGS

    DO NOT EXCEED RECOMMENDED DOSAGE

  • ASK DOCTOR

    ASK 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 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.

  • INACTIVE INGREDIENT

    Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

    pharmaceutical glaze, and sodium starch glycolate.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    WALGREENS URINARY PAIN RELIEF MAXIMUM STRENGTH 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0113
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 975
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0113-011 in 1 CARTON04/05/2010
    1NDC:0363-0113-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/05/2010
    Labeler - Walgreens Co. (008965063)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(0363-0113) , repack(0363-0113) , manufacture(0363-0113)