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

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

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Drug Label Information

Updated December 28, 2021

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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 US

  • 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.

  • HOW SUPPLIED

    NDC: 71335-1661-1: 6 Tablets in a BOTTLE

    NDC: 71335-1661-2: 12 Tablets in a BOTTLE

    NDC: 71335-1661-3: 36 Tablets in a BOTTLE

    NDC: 71335-1661-4: 20 Tablets in a BOTTLE

    NDC: 71335-1661-5: 10 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Phenazopyridine Hcl 97.5mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH  
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1661(NDC:49348-941)
    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, UNSPECIFIED FORM (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:71335-1661-16 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
    2NDC:71335-1661-212 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
    3NDC:71335-1661-336 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
    4NDC:71335-1661-420 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
    5NDC:71335-1661-510 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/18/2010
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1661) , RELABEL(71335-1661)
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