Label: QUALITY CHOICE MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

  • NDC Code(s): 63868-101-12
  • Packager: Chain Drug Marketing Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 30, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Phenazopyridine Hydrochloride 97.5 mg .

  • Purpose

    Urinary Analgesic

  • Warnings

    Do not exceed recommended dosage

  • Ask doctor before use if you have

    ■ kidney disease
    ■ allergies to food, preservatives or dyes
    ■ had a hypersensitive reaction to phenazopyridine

  • 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 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 reach of children

    In case of an overdose, get medical help or contact a Poison Control Center right away.

  • Use

    Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
    infections.

  • Inactive ingredients

    Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

  • Directions


    ■ adults and children 12 years and over:
    take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

    ■ children under 12 years: 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
    QUALITY CHOICE MAXIMUM STRENGTH URINARY PAIN RELIEF 
    phenazopyridine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-101
    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:63868-101-121 in 1 CARTON01/04/2010
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/04/2010
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(63868-101) , repack(63868-101)